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1. Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER).

Author

Van Bergen, Saskia H., Van Lieshout, Esther M. M., Mahabier, Kiran C., Geraerds, Alexandra J. L. M., Polinder, Suzanne, Den Hartog, Dennis, Verhofstad, Michael H. J., Beetz, Ivo, Bolhuis, Hugo W., Bos, P. Koen, Bronkhorst, Maarten W. G. A., Bruijninckx, Milko M. M., De Haan, Jeroen, Deenik, Axel R., Den Hoed, P. Ted, Eversdijk, Martin G., Goslings, J. Carel, Haverlag, Robert, Heetveld, Martin J., and Kerver, Albertus J. H.

Subjects
RESEARCH, HUMERAL fractures, COST benefit analysis, TREATMENT effectiveness, QUALITY of life, RESEARCH funding, QUESTIONNAIRES, DESCRIPTIVE statistics, LONGITUDINAL method
Abstract

Purpose: Operative treatment of a humeral shaft fracture results in faster recovery than nonoperative treatment. The cost-effectiveness, in terms of costs per Quality-Adjusted Life Year (QALY) gained (Dutch threshold €20,000-€80,000) or minimal important change (MIC) in disability reduced (DASH 6.7), is unknown. The aim of this study was to determine cost-utility and cost-effectiveness of operative versus nonoperative treatment in adults with a humeral shaft fracture type 12A or 12B. Methods: This study was performed alongside a multicenter prospective cohort study. Costs for health care and lost productivity until one year after trauma were calculated. The incremental cost-utility ratio (ICUR) was reported in costs per QALY (based on the EuroQoL-5D-3L (EQ-5D)) gained. The incremental cost-effectiveness ratio (ICER) was reported in costs per MIC (based on the DASH score at three months) reduced. Results: Overall, 245 patients were treated operatively and 145 nonoperatively. In the operative group, the mean total costs per patient (€11,925 versus €8793; p < 0.001) and QALYs (0.806 versus 0.778; p < 0.001) were higher. The ICUR of operative treatment was €111,860 per QALY gained (i.e., €3132/0.028). The DASH was 7.3 points (p < 0.001) lower in the operative group. The ICER of operative treatment was €2880 per MIC in disability reduced (i.e., €3132/7.3*6.7). Conclusion: Due to the limited effect of treatment on quality of life measured with the EQ-5D, the ICUR of operative treatment (€111,860 per QALY gained) exceeds the threshold. However, the incremental costs of €2880 per clinically meaningful difference in DASH are much lower and suggest that operative treatment for a humeral shaft fracture is cost-effective. [ABSTRACT FROM AUTHOR]

Published
2023
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2. Functional and clinical outcome after operative versus nonoperative treatment of a humeral shaft fracture (HUMMER): results of a multicenter prospective cohort study.

Author

Den Hartog, Dennis, Van Bergen, Saskia H., Mahabier, Kiran C., Verhofstad, Michael H. J., Van Lieshout, Esther M. M., the HUMMER Investigators, Beetz, Ivo, Bolhuis, Hugo W., Bos, P. Koen, Bronkhorst, Maarten W. G. A., Bruijninckx, Milko M. M., De Haan, Jeroen, Deenik, Axel R., Den Hoed, P. Ted, Eversdijk, Martin G., Goslings, J. Carel, Haverlag, Robert, Heetveld, Martin J., Kerver, Albertus J. H., and Kolkman, Karel A.

Subjects
RESEARCH, SUPINATION, RANGE of motion of joints, SHOULDER joint, ORTHOPEDIC implants, UNUNITED fractures, CLINICAL trials, HUMERAL fractures, AGE distribution, PRONATION, SURGERY, PATIENTS, VISUAL analog scale, SURGICAL complications, HEALTH surveys, GERIATRIC assessment, FUNCTIONAL assessment, TREATMENT effectiveness, SEX distribution, COMPARATIVE studies, FRACTURE fixation, REPEATED measures design, DESCRIPTIVE statistics, ABDUCTION (Kinesiology), ROTATIONAL motion, QUESTIONNAIRES, LONGITUDINAL method, FRACTURE healing, EVALUATION, DISEASE complications, ADULTS, MIDDLE age, OLD age
Abstract

Purpose: The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery. Methods: From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant–Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type. Results: Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant–Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001). Conclusion: Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group. Trial registration: NTR3617 (registration date 18-SEP-2012). [ABSTRACT FROM AUTHOR]

Published
2022
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3. Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

Author

McCormack, Robert, Apostle, Kelly, Moon, Raely, Bielby, Shea A., Switzer, Julie A., Cole, Peter A., Anderson, Sarah A., Lafferty, Paul M., Li, Mengnai, Ly, Thuan V., Marston, Scott B., Foley, Amy L., Vang, Sandy, Oatt, Amber, Wright, David M., Marcantonio, Andrew J., Kain, Michael S. H., Iorio, Richard, Specht, Lawrence M., Tilzey, John F., Lobo, Margaret J., Garfi, John S., Vallier, Heather A., Dolenc, Andrea, Buckley, Richard E., Robinson, Chalitha, Prayson, Michael J., Laughlin, Richard, Rubino, L. Joseph, May, Jedediah, Rieser, Geoffrey Ryan, Dulaney-Cripe, Liz, Gayton, Chris, Shaer, James, Schrickel, Tyson, Duffy, Paul, Hileman, Barbara, Gorczyca, John T., Gross, Jonathan M., Humphrey, Catherine A., Kates, Stephen, Noble, Krista, McIntyre, Allison W., Pecorella, Kaili, Davis, Craig A., Weinerman, Stewart, Korley, Robert, Weingarten, Peter, Stull, Philip, Lindenbaum, Stephen, Hewitt, Michael, Schwappach, John, Baker, Janell K., Rutherford, Tori, Newman, Heike, Lieberman, Shane, Finn, Erin, Puloski, Shannon, Robbins, Kristin, Hurley, Meghan, Lyle, Lindsey, Mitchell, Khalis, Browner, Kieran, Whatley, Erica, Payton, Krystal, Reeves, Christina, Cannada, Lisa K., Karges, David, Johnston, Kelly, Hill, Leslie, Mehta, Samir, Esterhai, John, Ahn, Jaimo, Horan, Annamarie D., McGinnis, Kelly, Kaminski, Christine A., Kowalski, Brynn N., Keeve, Jonathan P., Anderson, Christopher G., Powell, James, McDonald, Michael D., Hoffman, Jodi M., Tarkin, Ivan, Siska, Peter, Gruen, Gary, Evans, Andrew, Farrell, Dana J., Irrgang, James, Luther, Arlene, Cross III., William W., Carcary, Kimberly, Cass, Joseph R., Sems, Stephen A., Torchia, Michael E., Scrabeck, Tyson, Jenkins, Mark, Dumais, Jules, Romero, Amanda W., Sagebien, Carlos A., Butler, Mark S., Monica, James T., Sanders, David, Seuffert, Patricia, Hsu, Joseph R., Ficke, James, Charlton, Michael, Napierala, Matthew, Fan, Mary, Tornetta III., Paul, Tannoury, Chadi, Carlisle, Hope, Silva, Heather, Boyer, Dory, Lawendy, Abdel, Archdeacon, Michael, Finnan, Ryan, Le, Toan, Wyrick, John, Hess, Shelley, Brennan, Michael L., Probe, Robert, Kile, Evelyn, Mills, Kelli, Clipper, Lydia, Tieszer, Christina, Yu, Michelle, Erwin, Katie, Horwitz, Daniel, Strohecker, Kent, Swenson, Teresa K., Aurang, Kamran, Zohman, Gary, Peterson, Brett, Huff, Roger B., Baele, Joseph, Stephen, David, Weber, Timothy, Edison, Matt, McBeth, Jessica, Shively, Karl, Ertl, Janos P., Mullis, Brian, Parr, J. Andrew, Worman, Ripley, Frizzell, Valda, Moore, Molly M., Kreder, Hans, Tobias, Erin, Thomas, Emily, DePaolo, Charles J., Alosky, Rachel, Shell, Leslie E., Hampton, Lynne, Shepard, Stephanie, Nanney, Tracy, Cuento, Claudine, Cantu, Robert V., Jenkinson, Richard, Henderson, Eric R., Eickhoff, Linda S., Hammerberg, E. Mark, Stahel, Philip, Hak, David, Mauffrey, Cyril, Gibula, Douglas, Gissel, Hannah, Henderson, Corey, Zamorano, David P., Nousiainen, Markku, Tynan, Martin C., Pourmand, Deeba, Lawson, Deanna, Della Rocca, Gregory J., Crist, Brett D., Murtha, Yvonne M., Anderson, Linda K., Linehan, Colleen, Pilling, Lindsey, Lewis, Courtland G., Axelrod, Terry, Caminiti, Stephanie, Sullivan, Raymond J., Roper, Elizabeth, Obremskey, William, Kregor, Philip, Richards, Justin E., Stringfellow, Kenya, Dohm, Michael P., Zellar, Abby, Segers, Michiel J. M., Murnaghan, John, Zijl, Jacco A. C., Verhoeven, Bart, Smits, Anke B., de Vries, Jean Paul P. M., Fioole, Bram, van der Hoeven, Henk, Theunissen, Evert B. M., de Vries Reilingh, Tammo S., Govaert, Lonneke, Wittich, Philippe, Nam, Diane, de Brauw, Maurits, Wille, Jan, Go, Peter M. N. Y. M., Ritchie, Ewan D., Wessel, Ronald N., Hammacher, Eric R., Heetveld, Martin J., Visser, Gijs A., Stockmann, Heyn, Silvis, Rob, Wadey, Veronica, Snellen, Jaap P., Rijbroek, Bram, Scheepers, Joris J. G., Vermeulen, Erik G. J., Siroen, Michiel P. C., Vuylsteke, Ronald, Brom, Hans L. F., Rijna, Herman, de Rijcke, Piet A. R., Koppert, Cees L., Moola, Farhad, Yee, Albert, Buijk, Steven E., Groenendijk, Richard P. R., Dawson, Imro, Tetteroo, Geert W. M., Bruijninckx, Milko M. M., Doornebosch, Pascal G., de Graaf, Eelco J. R., van der Elst, Maarten, van der Pol, Carmen C., van 't Riet, Martijne, Milner, Katrine, Karsten, Tom M., de Vries, Mark R., Stassen, Laurents P. S., Schep, Niels W. L., Schmidt, G. Ben, Hoffman, W. H., Poolman, Rudolf W., Simons, Maarten P., van der Heijden, Frank H. W. M., Willems, W. Jaap, Kunz, Monica, de Meulemeester, Frank R. A. J., van der Hart, Cor P., Turckan, Kahn, Festen, Sebastiaan, de Nies, Frank, Haverlag, Robert, Out, Nico J. M., Bosma, Jan, van Kampen, Albert, Biert, Jan, Schemitsch, Emil H., van Vugt, Arie B., Edwards, Michael J. R., Blokhuis, Taco J., Frolke, Jan Paul M., Geeraedts, Leo M. G., Gardeniers, Jean W. M., Tan, Edward T. C. H., Poelhekke, Lodewijk M. S. J., de Waal Malefijt, Maarten C., Schreurs, Bart, Ahn, Henry, Roukema, Gert R., Josaputra, Hong A., Keller, Paul, de Rooij, Peter D., Kuiken, Hans, Boxma, Han, Cleffken, Berry I., Liem, Ronald, Rhemrev, Steven J., Bosman, Coks H. R., Hall, Jeremy A., de Mol van Otterloo, Alexander, Hoogendoorn, Jochem, de Vries, Alexander C., Meylaerts, Sven A. G., Verhofstad, Michiel H. J., Meijer, Joost, van Egmond, Teun, van der Brand, Igor, Patka, Peter, McKee, Michael D., Eversdijk, Martin G., Peters, Rolf, Den Hartog, Dennis, Van Waes, Oscar J. F., Oprel, Pim, van der Vis, Harm M., Campo, Martin, Verhagen, Ronald, Albers, G. H. Robert, Zurcher, Arthur W., Whelan, Daniel B., Simmermacher, Rogier K. J., van Mulken, Jeroen, van Wessem, Karlijn, van Gaalen, Steven M., Leenen, Luke, Bronkhorst, Maarten W. G. A., Guicherit, Onno R., Goslings, J. Carel, Nauth, Aaron, Ponsen, Kees Jan, Bhatia, Mahesh, Arora, Vinod, Tyagi, Vivek, Liew, Susan, Bedi, Harvinder, Carr, Ashley, Curry, Hamish, Chia, Andrew, Csongvay, Steve, Vicente, Milena R., Donohue, Craig, Doig, Stephen, Edwards, Elton, Etherington, Greg, Esser, Max, Gong, Andrew, Jain, Arvind, Li, Doug, Miller, Russell, Moaveni, Ash, Perey, Bertrand, Wild, Lisa M., Russ, Matthias, Ton, Lu, Wang, Otis, Dowrick, Adam, Murdoch, Zoe, Sage, Claire, Frihagen, Frede, Clarke-Jenssen, John, Hjorthaug, Geir, Ianssen, Torben, Khan, Ryan M., Amundsen, Asgeir, Brattgjerd, Jan Egil, Borch, Tor, Boe, Berthe, Flatoy, Bernhard, Hasselund, Sondre, Haug, Knut Jorgen, Hemlock, Kim, Hoseth, Tor Magne, Jomaas, Geir, Hidy, Jennifer T., Kibsgard, Thomas, Lona, Tarjei, Moatshe, Gilbert, Muller, Oliver, Molund, Marius, Nicolaisen, Tor, Nilsen, Fredrik, Rydinge, Jonas, Smedsrud, Morten, Stodle, Are, Coles, Chad, Trommer, Axel, Ugland, Stein, Karlsten, Anders, Ekas, Guri, Vesterhus, Elise Berg, Brekke, Anne Christine, Gupta, Ajay, Jain, Neeraj, Khan, Farah, Sharma, Ateet, Leighton, Ross, Sanghavi, Amir, Trivedi, Mittal, Rai, Anil, Subash, Rai, Kamal, Yadav, Vineet, Singh, Sanjay, Tetsworth, Kevin, Donald, Geoff, Biddulph, Michael, Weinrauch, Patrick, Pincus, Paul, Yang, Steven, Halliday, Brett, Gervais, Trevor, Holt, Michael, Flynn, Annette, Prasad, Amal Shankar, Mishra, Vimlesh, Sundaresh, D. C., Johnston, David, Khanna, Angshuman, Cherian, Joe Joseph, Olakkengil, Davy J., Sharma, Gaurav, Pirpiris, Marinis, Love, David, Bucknill, Andrew, Farrugia, Richard J., Pape, Hans-Christoph, Knobe, Matthias, Glazebrook, Mark, Pfeifer, Roman, Hull, Peter, Lewis, Sophie, Evans, Simone, Nanda, Rajesh, Logishetty, Rajanikanth, Anand, Sanjeev, Bowler, Carol, Dadi, Akhil, Palla, Naveen, Alexander, David, Ganguly, Utsav, Rai, B. Sachidananda, Rajakumar, Janakiraman, Jennings, Andrew, Chuter, Graham, Rose, Glynis, Horner, Gillian, Clark, Callum, Eke, Kate, Reed, Mike, Coady, Cathy, Herriott, Chris, Dobb, Christine, Bhandari, Mohit, Swiontkowski, Marc, Devereaux, Pj, Jeray, Kyle, Thabane, Lehana, Stone, Trevor, Dunbar, Michael, Walter, Stephen, Sprague, Sheila, Scott, Taryn, Guyatt, Gordon, Amirault, David, Viveiros, Helena, McKay, Paula, Swinton, Marilyn, Gross, Michael, Truong, Victoria, Koo, Kaitlin, Heels-Ansdell, Diane, Zhou, Qi, Buckingham, Lisa, Duraikannan, Aravin, Maddock, Deborah, Simunovic, Nicole, Agel, Julie, Oxner, William, Van Lieshout, Esther M. M., Zielinski, Stephanie M., Rangan, Amar, Hanusch, Birgit C., Kottam, Lucksy, Clarkson, Rachel, Reardon, Gerald, Slobogean, Gerard, Katz, Jeffrey, Gillespie, Brenda, Greendale, Gail A., Guy, Pierre, Hartman, Curtis, Rubin, Craig, Waddell, James, FAITH Investigators, Richardson, Glen, Trenholm, Andrew, Wong, Ivan, Trask, Kelly, MacDonald, Shelley, Viskontas, Darius, Dobbin, Gwen, Bicknell, Ryan, Yach, Jeff, Bardana, Davide, Wood, Gavin, Harrison, Mark, Yen, David, Lambert, Sue, Howells, Fiona, Ward, Angela, Lemke, H. Michael, Zalzal, Paul, Brien, Heather, Naumetz, V., Weening, Brad, Wai, Eugene K., Papp, Steve, Gofton, Wade T., Liew, Allen, Kingwell, Stephen P., Zomar, Mauri, Johnson, Garth, O'Neil, Joseph, Roffey, Darren M., Borsella, Vivian, Avram, Victoria, Oliver, Todd M., Jones, Vicki, Jones, Clifford B., Ringler, James R., Endres, Terrence J., Moon, Karyn, Sietsema, Debra L., Jeray, Kyle J., Broderick, J. Scott, Goetz, David R., Pace, Thomas B., Schaller, Thomas M., Porter, Scott E., Tanner, Stephanie L., Snider, Rebecca G., Nastoff, Lauren A., Surgery, Emergency Medicine, Obstetrics and Gynaecology, Other Research, Other departments, Graduate School, and AMS - Amsterdam Movement Sciences

Subjects
Time Factors, Sports medicine, medicine.medical_treatment, Bone Screws, Dentistry, Femoral Neck Fractures, law.invention, Fracture Fixation, Internal, Study Protocol, Postoperative Complications, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, law, Fracture fixation, Orthopedics and Sports Medicine, 030212 general & internal medicine, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Likelihood Functions, 030222 orthopedics, Femoral neck fractures, 3. Good health, Europe, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, Research Design, Hip fractures, Sliding hip screw, Reoperation, medicine.medical_specialty, Asia, Prosthesis Design, 03 medical and health sciences, Fixation (surgical), Rheumatology, medicine, Humans, Internal fixation, Proportional Hazards Models, business.industry, Australia, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], North America, Orthopedic surgery, Quality of Life, Cancellous screws, business
Abstract

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813 ).

Published
2014
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4. Publisher Correction: Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER).

Author

Van Bergen, Saskia H., Van Lieshout, Esther M. M., Mahabier, Kiran C., Geraerds, Alexandra J. L. M., Polinder, Suzanne, Den Hartog, Dennis, Verhofstad, Michael H. J., Beetz, Ivo, Bolhuis, Hugo W., Bos, P. Koen, Bronkhorst, Maarten W. G. A., Bruijninckx, Milko M. M., De Haan, Jeroen, Deenik, Axel R., Den Hoed, P. Ted, Eversdijk, Martin G., Goslings, J. Carel, Haverlag, Robert, Heetveld, Martin J., and Kerver, Albertus J. H.

Subjects
HUMERAL fractures, MEDICAL care costs, FRACTURE fixation
Abstract

A correction for the article "Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER)" is presented, which is published in the February 6, 2023 issue of the periodical.

Published
2023
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5. Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

Author

de Haan, Jeroen, den Hartog, Dennis, Tuinebreijer, Wim E., Iordens, Gijs I. T., Breederveld, Roelf S., Bronkhorst, Maarten W. G. A., Bruijninckx, Milko M. M., Vries, Mark R. De, Dwars, Boudewijn J., Eygendaal, Denise, Haverlag, Robert, Meylaerts, Sven A. G., Mulder, Jan-Willem R, Ponsen, Kees J., Roerdink, W. Herbert, Roukema, Gert R., Schipper, Inger B., Schouten, Michel A., Sintenie, Jan Bernard, and Sivro, Senail

Subjects
JOINT dislocations, RANDOMIZED controlled trials, CLINICAL medicine research, BONE fractures, MUSCULOSKELETAL system diseases
Abstract

Background: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for prosupination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. Discussion: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. Trial Registration: The trial is registered at the Netherlands Trial Register (NTR2025). [ABSTRACT FROM AUTHOR]

Published
2010
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6. Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

Author

McCormack, Robert, Apostle, Kelly, Boyer, Dory, Moola, Farhad, Perey, Bertrand, Stone, Trevor, Viskontas, Darius, Lemke, H. Michael, Zomar, Mauri, Moon, Karyn, Moon, Raely, Oatt, Amber, Buckley, Richard E., Duffy, Paul, Korley, Robert, Puloski, Shannon, Johnston, Kelly, Powell, James, Carcary, Kimberly, Sanders, David, Lawendy, Abdel, Tieszer, Christina, Stephen, David, Kreder, Hans, Jenkinson, Richard, Nousiainen, Markku, Axelrod, Terry, Murnaghan, John, Nam, Diane, Wadey, Veronica, Yee, Albert, Milner, Katrine, Kunz, Monica, Schemitsch, Emil H., Ahn, Henry, Hall, Jeremy A., McKee, Michael D., Whelan, Daniel B., Nauth, Aaron, Vicente, Milena R., Wild, Lisa M., Khan, Ryan M., Hidy, Jennifer T., Coles, Chad, Leighton, Ross, Biddulph, Michael, Johnston, David, Glazebrook, Mark, Alexander, David, Coady, Cathy, Dunbar, Michael, Amirault, David, Gross, Michael, Oxner, William, Reardon, Gerald, Richardson, Glen, Trenholm, Andrew, Wong, Ivan, Trask, Kelly, MacDonald, Shelley, Dobbin, Gwen, Bicknell, Ryan, Yach, Jeff, Bardana, Davide, Wood, Gavin, Harrison, Mark, Yen, David, Lambert, Sue, Howells, Fiona, Ward, Angela, Zalzal, Paul, Brien, Heather, Naumetz, V., Weening, Brad, Simunovic, Nicole, Wai, Eugene K., Papp, Steve, Gofton, Wade T., Liew, Allen, Kingwell, Stephen P., Johnson, Garth, O'Neil, Joseph, Roffey, Darren M., Borsella, Vivian, Avram, Victoria, Oliver, Todd M., Jones, Vicki, Jones, Clifford B., Ringler, James R., Endres, Terrence J., Sietsema, Debra L., Jeray, Kyle J., Broderick, J. Scott, Goetz, David R., Pace, Thomas B., Schaller, Thomas M., Porter, Scott E., Tanner, Stephanie L., Snider, Rebecca G., Nastoff, Lauren A., Bielby, Shea A., Switzer, Julie A., Cole, Peter A., Anderson, Sarah A., Lafferty, Paul M., Li, Mengnai, Ly, Thuan V., Marston, Scott B., Foley, Amy L., Vang, Sandy, Wright, David M., Marcantonio, Andrew J., Kain, Michael S. H., Iorio, Richard, Specht, Lawrence M., Tilzey, John F., Lobo, Margaret J., Garfi, John S., Vallier, Heather A., Dolenc, Andrea, Robinson, Chalitha, Prayson, Michael J., Laughlin, Richard, Rubino, L. Joseph, May, Jedediah, Rieser, Geoffrey Ryan, Dulaney-Cripe, Liz, Gayton, Chris, Shaer, James, Schrickel, Tyson, Hileman, Barbara, Gorczyca, John T., Gross, Jonathan M., Humphrey, Catherine A., Kates, Stephen, Noble, Krista, McIntyre, Allison W., Pecorella, Kaili, Davis, Craig A., Weinerman, Stewart, Weingarten, Peter, Stull, Philip, Lindenbaum, Stephen, Hewitt, Michael, Schwappach, John, Baker, Janell K., Rutherford, Tori, Newman, Heike, Lieberman, Shane, Finn, Erin, Robbins, Kristin, Hurley, Meghan, Lyle, Lindsey, Mitchell, Khalis, Browner, Kieran, Whatley, Erica, Payton, Krystal, Reeves, Christina, Cannada, Lisa K., Karges, David, Hill, Leslie, Mehta, Samir, Esterhai, John, Ahn, Jaimo, Horan, Annamarie D., McGinnis, Kelly, Kaminski, Christine A., Kowalski, Brynn N., Keeve, Jonathan P., Anderson, Christopher G., McDonald, Michael D., Hoffman, Jodi M., Tarkin, Ivan, Siska, Peter, Gruen, Gary, Evans, Andrew, Farrell, Dana J., Irrgang, James, Luther, Arlene, Cross III., William W., Cass, Joseph R., Sems, Stephen A., Torchia, Michael E., Scrabeck, Tyson, Jenkins, Mark, Dumais, Jules, Romero, Amanda W., Sagebien, Carlos A., Butler, Mark S., Monica, James T., Seuffert, Patricia, Hsu, Joseph R., Ficke, James, Charlton, Michael, Napierala, Matthew, Fan, Mary, Tornetta III., Paul, Tannoury, Chadi, Carlisle, Hope, Silva, Heather, Archdeacon, Michael, Finnan, Ryan, Le, Toan, Wyrick, John, Hess, Shelley, Brennan, Michael L., Probe, Robert, Kile, Evelyn, Mills, Kelli, Clipper, Lydia, Yu, Michelle, Erwin, Katie, Horwitz, Daniel, Strohecker, Kent, Swenson, Teresa K., Aurang, Kamran, Zohman, Gary, Peterson, Brett, Huff, Roger B., Baele, Joseph, Weber, Timothy, Edison, Matt, McBeth, Jessica, Shively, Karl, Ertl, Janos P., Mullis, Brian, Parr, J. Andrew, Worman, Ripley, Frizzell, Valda, Moore, Molly M., Tobias, Erin, Thomas, Emily, DePaolo, Charles J., Alosky, Rachel, Shell, Leslie E., Hampton, Lynne, Shepard, Stephanie, Nanney, Tracy, Cuento, Claudine, Cantu, Robert V., Henderson, Eric R., Eickhoff, Linda S., Hammerberg, E. Mark, Stahel, Philip, Hak, David, Mauffrey, Cyril, Gibula, Douglas, Gissel, Hannah, Henderson, Corey, Zamorano, David P., Tynan, Martin C., Pourmand, Deeba, Lawson, Deanna, Della Rocca, Gregory J., Crist, Brett D., Murtha, Yvonne M., Anderson, Linda K., Linehan, Colleen, Pilling, Lindsey, Lewis, Courtland G., Caminiti, Stephanie, Sullivan, Raymond J., Roper, Elizabeth, Obremskey, William, Kregor, Philip, Richards, Justin E., Stringfellow, Kenya, Dohm, Michael P., Zellar, Abby, Segers, Michiel J. M., Zijl, Jacco A. C., Verhoeven, Bart, Smits, Anke B., De Vries, Jean Paul P. M., Fioole, Bram, Van Der Hoeven, Henk, Theunissen, Evert B. M., De Vries Reilingh, Tammo S., Govaert, Lonneke, Wittich, Philippe, De Brauw, Maurits, Wille, Jan, Go, Peter M. N. Y. M., Ritchie, Ewan D., Wessel, Ronald N., Hammacher, Eric R., Heetveld, Martin J., Visser, Gijs A., Stockmann, Heyn, Silvis, Rob, Snellen, Jaap P., Rijbroek, Bram, Scheepers, Joris J. G., Vermeulen, Erik G. J., Siroen, Michiel P. C., Vuylsteke, Ronald, Brom, Hans L. F., Rijna, Herman, De Rijcke, Piet A. R., Koppert, Cees L., Buijk, Steven E., Groenendijk, Richard P. R., Dawson, Imro, Tetteroo, Geert W. M., Bruijninckx, Milko M. M., Doornebosch, Pascal G., De Graaf, Eelco J. R., Van Der Elst, Maarten, Van Der Pol, Carmen C., Van 'T Riet, Martijne, Karsten, Tom M., De Vries, Mark R., Stassen, Laurents P. S., Schep, Niels W. L., Ben Schmidt, G., Hoffman, W. H., Poolman, Rudolf W., Simons, Maarten P., Van Der Heijden, Frank H. W. M., Willems, W. Jaap, De Meulemeester, Frank R. A. J., Van Der Hart, Cor P., Turckan, Kahn, Festen, Sebastiaan, De Nies, Frank, Haverlag, Robert, Out, Nico J. M., Bosma, Jan, Van Kampen, Albert, Biert, Jan, Van Vugt, Arie B., Edwards, Michael J. R., Blokhuis, Taco J., Frolke, Jan Paul M., Geeraedts, Leo M. G., Gardeniers, Jean W. M., Tan, Edward T. C. H., Poelhekke, Lodewijk M. S. J., De Waal Malefijt, Maarten C., Schreurs, Bart, Roukema, Gert R., Josaputra, Hong A., Keller, Paul, De Rooij, Peter D., Kuiken, Hans, Boxma, Han, Cleffken, Berry I., Liem, Ronald, Rhemrev, Steven J., Bosman, Coks H. R., De Mol Van Otterloo, Alexander, Hoogendoorn, Jochem, De Vries, Alexander C., Meylaerts, Sven A. G., Verhofstad, Michiel H. J., Meijer, Joost, Van Egmond, Teun, Van Der Brand, Igor, Patka, Peter, Eversdijk, Martin G., Peters, Rolf, Den Hartog, Dennis, Van Waes, Oscar J. F., Oprel, Pim, Van Der Vis, Harm M., Campo, Martin, Verhagen, Ronald, Albers, G. H. Robert, Zurcher, Arthur W., Simmermacher, Rogier K. J., Van Mulken, Jeroen, Van Wessem, Karlijn, Van Gaalen, Steven M., Leenen, Luke, Bronkhorst, Maarten W. G. A., Guicherit, Onno R., Goslings, J. Carel, Ponsen, Kees Jan, Bhatia, Mahesh, Arora, Vinod, Tyagi, Vivek, Liew, Susan, Bedi, Harvinder, Carr, Ashley, Curry, Hamish, Chia, Andrew, Csongvay, Steve, Donohue, Craig, Doig, Stephen, Edwards, Elton, Etherington, Greg, Esser, Max, Gong, Andrew, Jain, Arvind, Li, Doug, Miller, Russell, Moaveni, Ash, Russ, Matthias, Ton, Lu, Wang, Otis, Dowrick, Adam, Murdoch, Zoe, Sage, Claire, Frihagen, Frede, Clarke-Jenssen, John, Hjorthaug, Geir, Ianssen, Torben, Amundsen, Asgeir, Brattgjerd, Jan Egil, Borch, Tor, Boe, Berthe, Flatoy, Bernhard, Hasselund, Sondre, Haug, Knut Jorgen, Hemlock, Kim, Hoseth, Tor Magne, Jomaas, Geir, Kibsgard, Thomas, Lona, Tarjei, Moatshe, Gilbert, Muller, Oliver, Molund, Marius, Nicolaisen, Tor, Nilsen, Fredrik, Rydinge, Jonas, Smedsrud, Morten, Stodle, Are, Trommer, Axel, Ugland, Stein, Karlsten, Anders, Ekas, Guri, Vesterhus, Elise Berg, Brekke, Anne Christine, Gupta, Ajay, Jain, Neeraj, Khan, Farah, Sharma, Ateet, Sanghavi, Amir, Trivedi, Mittal, Rai, Anil, Subash, Rai, Kamal, Yadav, Vineet, Singh, Sanjay, Tetsworth, Kevin, Donald, Geoff, Weinrauch, Patrick, Pincus, Paul, Yang, Steven, Halliday, Brett, Gervais, Trevor, Holt, Michael, Flynn, Annette, Prasad, Amal Shankar, Mishra, Vimlesh, Sundaresh, D. C., Khanna, Angshuman, Cherian, Joe Joseph, Olakkengil, Davy J., Sharma, Gaurav, Pirpiris, Marinis, Love, David, Bucknill, Andrew, Farrugia, Richard J., Pape, Hans-Christoph, Knobe, Matthias, Pfeifer, Roman, Hull, Peter, Lewis, Sophie, Evans, Simone, Nanda, Rajesh, Logishetty, Rajanikanth, Anand, Sanjeev, Bowler, Carol, Dadi, Akhil, Palla, Naveen, Ganguly, Utsav, Rai, B. Sachidananda, Rajakumar, Janakiraman, Jennings, Andrew, Chuter, Graham, Rose, Glynis, Horner, Gillian, Clark, Callum, Eke, Kate, Reed, Mike, Herriott, Chris, Dobb, Christine, Bhandari, Mohit, Swiontkowski, Marc, Devereaux, Pj, Jeray, Kyle, Thabane, Lehana, Walter, Stephen, Sprague, Sheila, Scott, Taryn, Guyatt, Gordon, Viveiros, Helena, McKay, Paula, Swinton, Marilyn, Truong, Victoria, Koo, Kaitlin, Heels-Ansdell, Diane, Zhou, Qi, Buckingham, Lisa, Duraikannan, Aravin, Maddock, Deborah, Agel, Julie, Van Lieshout, Esther M. M., Zielinski, Stephanie M., Rangan, Amar, Hanusch, Birgit C., Kottam, Lucksy, Clarkson, Rachel, Slobogean, Gerard, Katz, Jeffrey, Gillespie, Brenda, Greendale, Gail A., Guy, Pierre, Hartman, Curtis, Rubin, Craig, Waddell, James, and FAITH Investigators

Subjects
3. Good health
Abstract

BMC musculoskeletal disorders 15, 219 (2014). doi:10.1186/1471-2474-15-219, Published by BioMed Central, London

7. [Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

Author

Hartholt, Klaas A, Van der Velde, Nathalie, Van Lieshout, Esther M M, Polinder, Suzanne, De Vries, Oscar J, Boyé, Nicole D A, Kerver, Albert J H, Ziere, Gijsbertus, Bruijninckx, Milko M M, De Vries, Mark R, Mattace-Raso, Francesco U S, Uitterlinden, André G, Van Beeck, Ed F, Lips, Paul, Patka, Peter, and Van der Cammen, Tischa J M

Abstract

Background: Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall.Methods/design: A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis.Discussion: The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction.Trial Registration: The trial is registered in the Netherlands Trial Register (NTR1593). [ABSTRACT FROM AUTHOR]

Published
2011
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8. Redisplacement of reduced distal radius fractures in adults: does the type of casting play a role? The CAST study, a multicentre cluster randomized controlled trial.

Author

Barvelink B, Reijman M, Smidt S, Miranda Afonso P, Verhaar JAN, Colaris JW, van Beek F, Bouwhuis MG, Bruijninckx MMM, Greeven APA, Gosens T, Kok MJ, Kokke MC, Kraan GA, van Lakwijk K, Leijnen M, van Loon M, van Rijssel DA, Schep NWL, Scholtens L, Wijffels MME, Slebioda N, van der Zwaal P, and Zwets E

Subjects
Humans, Male, Female, Middle Aged, Aged, Adult, Splints, Treatment Outcome, Patient Reported Outcome Measures, Wrist Fractures, Casts, Surgical, Radius Fractures therapy
Abstract

Aims: It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer the redisplacement of fewer fractures and better one-year outcomes compared with plaster splinting., Methods: In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure., Results: The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur., Conclusion: Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups., Competing Interests: None declared., (© 2024 Barvelink et al.)

Published
2024
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9. Effect of the Dutch Hip Fracture Audit implementation on mortality, length of hospital stay and time until surgery in elderly hip fracture patients; a multi-center cohort study.

Author

van Voorden TAJ, den Hartog D, Soesman NMR, Jakma TSC, Waleboer M, Staarink M, Bruijninckx MMM, Nijman F, Knops SP, Lieshout EMMV, and Schep NWL

Subjects
Aged, Aged, 80 and over, Female, Hospital Mortality, Humans, Logistic Models, Male, Medical Audit, Netherlands, Retrospective Studies, Time Factors, Hip Fractures mortality, Hip Fractures therapy, Length of Stay statistics & numerical data, Quality of Health Care statistics & numerical data
Abstract

Background: In 2040 the estimated number of people with a hip fracture in the Netherlands will be about 24,000. The medical care for this group of patients is complicated and challenging. Multidisciplinary approaches aim to improve clinical outcome. Quality indicators that gain insight in the treatment and outcome of hip fracture patients may help to optimize and monitor the standard of medical care. The Dutch Hip Fracture Audit (DHFA) is a new multidisciplinary quality indicator that is implemented in the Dutch hospitals in 2017., Aim: The aim of this study was to determine the effect of the implementation of the DHFA on 30-day mortality, length of hospital stay and time until surgery in elderly with a hip fracture in the Netherlands., Methods: A multicenter retrospective comparative cohort study was conducted and data were extracted from the Dutch Nationwide Trauma Registration (LTR). Included were patients aged 60 years and older with a hip fracture (femoral neck and trochanteric) and admitted in one of the ten participating hospitals registered in 2015 and 2017. Data from 2015, before implementation of DHFA, were compared with data from 2017, when the DHFA was implemented. The primary outcome was 30-day mortality; secondary outcomes were length of hospital stay and time until surgery. Multivariable regression models were used to compare outcomes between groups., Results: 3808 patients were included, 1839 in the 2015 cohort and 1969 in the 2017 cohort. 29% was male; mean age 82 years. The multilevel analysis showed a positive non-significant difference between groups on the primary outcome30-day mortality (OR adjusted 1.23, 95%CI 0.93 - 1.63). The secondary outcomes length of hospital stay (adjusted effect estimates -0.002, 95%CI -0.03 - 0.03) and time until surgery (adjusted effect estimates 0.292, 95%CI -2.68 - 3.26) showed no differences between groups., Conclusions: Implementation of the DHFA quality indicator does have a positive non-significant trend on 30-day mortality, but showed no impact on length of hospital stay and time until surgery. More research on relevant quality indicators seems therefore mandatory., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2020
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10. Circumstances leading to injurious falls in older men and women in the Netherlands.

Author

Boyé ND, Mattace-Raso FU, Van der Velde N, Van Lieshout EM, De Vries OJ, Hartholt KA, Kerver AJ, Bruijninckx MM, Van der Cammen TJ, Patka P, and Van Beeck EF

Subjects
Accidental Falls mortality, Activities of Daily Living, Aged, Aged, 80 and over, Brain Injuries etiology, Brain Injuries mortality, Female, Health Knowledge, Attitudes, Practice, Hip Fractures etiology, Hip Fractures mortality, Humans, Male, Netherlands epidemiology, Quality of Life, Risk Factors, Walking, Accident Prevention, Accidental Falls prevention & control, Brain Injuries prevention & control, Emergency Service, Hospital statistics & numerical data, Frail Elderly, Hip Fractures prevention & control, Public Health
Abstract

Background: Fall-induced injuries in persons aged 65 years and older are a major public health problem. Data regarding circumstances leading to specific injuries, such as traumatic brain injury (TBI) and hip fractures in older adults are scarce., Objective: To investigate the activity distributions leading to indoor and outdoor falls requiring an emergency department (ED) visit, and those resulting in TBIs and hip fractures., Participants: 5880 older adults who visited the ED due to a fall., Methods: Data is descriptive and stratified by age and gender., Results: Two-thirds of all falls occurred indoors. However, there were higher proportions of outdoor falls at ages 65-79 years (48%). Walking up or down stairs (51%) and housekeeping (17%) were the most common indoor activities leading to a TBIs. Walking (42%) and sitting or standing (16%) was the most common indoor activities leading to a hip fracture. The most common outdoor activities were walking (61% for TBIs and 57% for hip fractures) and cycling (10% for TBIs and 24% for hip fractures)., Conclusion: In the present study we found that the indoor activities distribution leading to TBIs and hip fractures differed. Notably, about half of the traumatic brain injuries and hip fractures in men and women aged 65-79 years occurred outdoors. This study provides new insights into patterns leading to injurious falls by age, gender and injury type, and may guide the targeting of falls prevention at specific activities and risk groups, including highly functional older men and women., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Published
2014
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11. HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

Author

Mahabier KC, Van Lieshout EM, Bolhuis HW, Bos PK, Bronkhorst MW, Bruijninckx MM, De Haan J, Deenik AR, Dwars BJ, Eversdijk MG, Goslings JC, Haverlag R, Heetveld MJ, Kerver AJ, Kolkman KA, Leenhouts PA, Meylaerts SA, Onstenk R, Poeze M, Poolman RW, Punt BJ, Roerdink WH, Roukema GR, Sintenie JB, Soesman NM, Tanka AK, Ten Holder EJ, Van der Elst M, Van der Heijden FH, Van der Linden FM, Van der Zwaal P, Van Dijk JP, Van Jonbergen HP, Verleisdonk EJ, Vroemen JP, Waleboer M, Wittich P, Zuidema WP, Polinder S, Verhofstad MH, and Den Hartog D

Subjects
Activities of Daily Living, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Fracture Fixation economics, Health Care Costs, Humans, Humeral Fractures diagnosis, Humeral Fractures economics, Humeral Fractures physiopathology, Humeral Fractures surgery, Netherlands, Pain Measurement, Prospective Studies, Recovery of Function, Return to Work, Surveys and Questionnaires, Time Factors, Treatment Outcome, Fracture Fixation methods, Fracture Healing, Humeral Fractures therapy, Research Design
Abstract

Background: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery., Methods/design: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective., Discussion: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture., Trial Registration: The trial is registered at the Netherlands Trial Register (NTR3617).

Published
2014
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