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7. Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study

Author

Tronstad, Sara, Haug, Knut Jørgen, Myklebust, Tor Åge, Weber, Clemens, Brisby, Helena, Austevoll, Ivar Magne, Hellum, Christian, Storheim, Kjersti, Aaen, Jørn, Banitalebi, Hasan, Brox, Jens Ivar, Grundnes, Oliver, Franssen, Eric, Indrekvam, Kari, Solberg, Tore, and Hermansen, Erland

Published
2024
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9. Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial)

Author

Hellum, Christian, Rekeland, Frode, Småstuen, Milada Cvancarova, Solberg, Tore, Hermansen, Erland, Storheim, Kjersti, Brox, Jens Ivar, Furunes, Håvard, Franssen, Eric, Weber, Clemens, Brisby, Helena, Grundnes, Oliver, Algaard, Knut Robert Hector, Böker, Tordis, Banitalebi, Hasan, Indrekvam, Kari, and Austevoll, Ivar Magne

Published
2023
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12. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis – study protocol for the MultiKnee trial

Author

Lindberg, Maren Falch, Aamodt, Arild, Badawy, Mona, Bergvad, Ingvild B, Borchgrevink, Petter, Furnes, Ove, Gay, Caryl, Heir, Stig, Holm, Inger, Indrekvam, Kari, Kise, Nina, Lau, Bjørn, Magnussen, Jon, Nerhus, Tor Kjetil, Rognsvåg, Turid, Rudsengen, Daniil E, Rustøen, Tone, Skou, Søren T, Stubberud, Jan, Småstuen, Milada S, and Lerdal, Anners

Subjects
Allied Health and Rehabilitation Science, Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Clinical Trials and Supportive Activities, Pain Research, Aging, Cost Effectiveness Research, Arthritis, Mind and Body, Clinical Research, Comparative Effectiveness Research, Chronic Pain, Rehabilitation, 6.7 Physical, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.4 Surgery, Musculoskeletal, Good Health and Well Being, Quality Education, Adolescent, Adult, Aged, Aged, 80 and over, Arthroplasty, Replacement, Knee, Cognitive Behavioral Therapy, Exercise Therapy, Humans, Middle Aged, Osteoarthritis, Knee, Quality of Life, Randomized Controlled Trials as Topic, Young Adult, Total knee arthroplasty, Osteoarthritis, Cognitive behavioral therapy, Exercise therapy, Orthopedics, Clinical sciences, Allied health and rehabilitation science, Sports science and exercise
Abstract

BackgroundOne in five patients report chronic pain following total knee arthroplasty (TKA) and are considered non-improvers. Psychological interventions such as cognitive behavioral therapy (CBT), combined with exercise therapy and education may contribute to reduced pain an improved function both for patients with OA or after TKA surgery, but the evidence for the effectiveness of such interventions is scarce. This randomized controlled trial with three arms will compare the clinical effectiveness of patient education and exercise therapy combined with internet-delivered CBT (iCBT), evaluated either as a non-surgical treatment choice or in combination with TKA, in comparison to usual treatment with TKA in patients with knee OA who are considered candidates for TKA surgery.MethodsThe study, conducted in three orthopaedic centers in Norway will include 282 patients between ages 18 and 80, eligible for TKA. Patients will be randomized to receive the exercise therapy + iCBT, either alone or in combination with TKA, or to a control group who will undergo conventional TKA and usual care physiotherapy following surgery. The exercise therapy will include 24 one hour sessions over 12 weeks led by a physiotherapist. The iCBT program will be delivered in ten modules. The physiotherapists will receive theoretical and practical training to advise and mentor the patients during the iCBT program. The primary outcome will be change from baseline to 12 months on the pain sub-scale from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the remaining 4 sub-scales from the KOOS (symptoms, function in daily living, function in sports and recreation, and knee-related quality of life), EQ-5D-5L, the Pain Catastrophizing Scale, the 30-s sit-to-stand test, 40-m walking test and ActiGraph activity measures. A cost-utility analysis will be performed using QALYs derived from the EQ-5D-5L and registry data.DiscussionThis is the first randomized controlled trial to investigate the effectiveness of exercise therapy and iCBT with or without TKA, to optimize outcomes for TKA patients. Findings from this trial will contribute to evidence-based personalized treatment recommendations for a large proportion of OA patients who currently lack an effective treatment option.Trial registrationClinicaltrials.gov : NCT03771430 . Registered: Dec 11, 2018.

Published
2021

14. Comparison of Patients Operated for Lumbar Spinal Stenosis with and without Spondylolisthesis – A Secondary Analysis of the NORDSTEN Trials

Author

Weber, Clemens, primary, Hermansen, Erland, additional, Myklebust, Tor Åge, additional, Banitalebi, Hasan, additional, Brisby, Helena, additional, Brox, Jens Ivar, additional, Franssen, Eric, additional, Hellum, Christian, additional, Indrekvam, Kari, additional, Harboe, Knut, additional, Rekeland, Frode, additional, Solberg, Tore, additional, Storheim, Kjersti, additional, and Austevoll, Ivar Magne, additional

Published
2024
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15. Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial

Author

Åkerstedt, Josefin, primary, Wänman, Johan, additional, Banitalebi, Hasan, additional, Myklebust, Tor Åge, additional, Weber, Clemens, additional, Storheim, Kjersti, additional, Hellum, Christian, additional, Indrekvam, Kari, additional, Hermansen, Erland, additional, and Brisby, Helena, additional

Published
2024
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17. Postoperative Dural Sac Cross-Sectional Area as an Association for Outcome After Surgery for Lumbar Spinal Stenosis: Clinical and Radiological Results From the NORDSTEN-Spinal Stenosis Trial

Author

Hermansen, Erland, Myklebust, Tor Å., Weber, Clemens, Brisby, Helena, Austevoll, Ivar M., Hellum, Christian, Storheim, Kjersti, Aaen, Jørn, Banitalebi, Hasan, Brox, Jens I., Grundnes, Oliver, Rekeland, Frode, Solberg, Tore, Franssen, Eric, and Indrekvam, Kari

Published
2023
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20. Change in lumbar lordosis after decompressive surgery in lumbar spinal stenosis patients and associations with patient related outcomes 2 years after surgery : radiological and clinical results from the NORDSTEN spinal stenosis trial

Author

Åkerstedt, Josefin, Wänman, Johan, Banitalebi, Hasan, Myklebust, Tor Åge, Weber, Clemens, Storheim, Kjersti, Hellum, Christian, Indrekvam, Kari, Hermansen, Erland, Brisby, Helena, Åkerstedt, Josefin, Wänman, Johan, Banitalebi, Hasan, Myklebust, Tor Åge, Weber, Clemens, Storheim, Kjersti, Hellum, Christian, Indrekvam, Kari, Hermansen, Erland, and Brisby, Helena

Abstract

Study design: A prospective cohort study. Objective: The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). Summary of background: Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. Method: Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. Results: LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees (P=0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI (P=0.022) and ZCQ function (P=0.016) in the adjusted analyses, but was not significant for back and leg pain Conclusion: Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Published
2024
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22. Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study

Author

Hermansen, Erland, Austevoll, Ivar Magne, Hellum, Christian, Storheim, Kjersti, Myklebust, Tor Åge, Aaen, Jørn, Banitalebi, Hasan, Anvar, Masoud, Rekeland, Frode, Brox, Jens Ivar, Franssen, Eric, Weber, Clemens, Solberg, Tore, Haug, Knut Jørgen, Grundnes, Oliver, Brisby, Helena, and Indrekvam, Kari

Published
2020
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23. The Influence of Spinous Process Union on Clinical Outcomes After Spinous Process Osteotomy for Lumbar Spinal Stenosis After 2 Years: A Secondary Analysis From the NORDSTEN-Study.

Author

HAGERUP, SONDRE, BROX, JENS IVAR, BANITALEBI, HASAN, INDREKVAM, KARI, MYKLEBUST, TOR ÅGE, and HERMANSEN, ERLAND

Subjects
SPINAL stenosis, OSTEOTOMY, SURGICAL decompression, COMPUTED tomography, LUMBAR pain
Abstract

Background: Lumbar spinal stenosis is a prevalent and increasingly important cause of low back pain, leg pain, and walking impairment. Minimally invasive decompressive techniques such as spinous process (SP) osteotomy have become more common in recent years. The main aim of this study was to investigate the proportion of complete SP union and whether complete radiological healing after the osteotomy is associated with superior clinical outcome after 2 years. Methods: In this retrospective cohort study, 149 patients were included from the Spinal Stenosis Trial, a part of the NORwegian Degenerative spondylolisthesis and spinal STENosis study. Computed tomography imaging was performed 2 years postoperatively. The number of osteotomies and the number of SP unions were recorded. Patients were divided into groups based on the degree of union: nonunion, partial union, and complete union. Rate of success (>30% improvement in Oswestry Disability Index [ODI]) and mean change in ODI were the primary outcome measures. We compared the differences between baseline and follow-up between the Degree of Union groups. Results: The study included 102 of 149 eligible patients. Ten patients (9.8%) were classified as having nonunion, 15 (14.7%) as having partial union, and 77 (75.5%) as having complete union. Of the 155 osteotomies, there were 122 classified as union (77%). The success rate was 74%, with no influence of SP union. The mean change in the ODI was -20.1 (95% CI -37.0, 14.2) with no influence of SP union. Conclusions: We found no influence of SP union, classified by computed tomography, on clinical outcome 2 years after SP osteotomy in patients with lumbar spinal stenosis. Clinical Relevance: Supplying useful information about SPO to assist surgeons in the choice of decompressive technique. Level of Evidence: 2. Lumbar Spine. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Author

Austevoll, Ivar Magne, Gjestad, Rolf, Grotle, Margreth, Solberg, Tore, Brox, Jens Ivar, Hermansen, Erland, Rekeland, Frode, Indrekvam, Kari, Storheim, Kjersti, and Hellum, Christian

Published
2019
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27. Exercise therapy, education and cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis: A randomized feasibility study

Author

Rognsvag, Turid, primary, Bergvad, Ingvild Buset, additional, Furnes, Ove Nord, additional, Indrekvam, Kari, additional, Lerdal, Anners, additional, Lindberg, Maren Falch, additional, Skou, Søren Thorgaard, additional, Stubberud, Jan, additional, and Badawy, Mona, additional

Published
2022
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32. Similarly low blood metal ion levels at 10‐years follow‐up of total hip arthroplasties with Oxinium, CoCrMo, and stainless steel femoral heads. Data from a randomized clinical trial.

Author

Høl, Paul Johan, Hallan, Geir, Furnes, Ove, Fenstad, Anne Marie, Indrekvam, Kari, and Kadar, Thomas

Subjects
FEMUR head, CLINICAL trials, STAINLESS steel, METAL ions, TOTAL hip replacement
Abstract

The use of inert head materials such as ceramic heads has been proposed as a method of reducing wear and corrosion products from the articulating surfaces in total hip arthroplasty, as well as from the stem‐head taper connection. The aim of the present study was to compare the blood metal ion levels in patients with Oxinium and CoCrMo modular femoral heads, as well as monoblock stainless steel Charnley prostheses at 10 years postoperatively. The 150 patients with osteoarthritis of the hip joint included in a randomized clinical trial were grouped according to femoral head material. One group (n = 30) had received the Charnley monoblock stainless steel stem (DePuy, UK). The other patients (n = 120) received a Spectron EF CoCrMo stem with either a 28 mm CoCrMo or Oxinium modular head (Smith & Nephew, USA). After 10 years, 38 patients had withdrawn, 19 deceased, 7 revised due to aseptic loosening and 5 revised due to infection. The 81 patients with median age of 79 years (70–91) were available for whole blood metal ion analysis. The levels of Co, Cr, Ni and Zr in the blood were generally low with all the head materials (medians <0.3 micrograms/L) and no statistical difference between the groups were found (p =.2–.8). Based on the low blood metal ion values in our study groups, no indication of severe trunnion corrosion in patients with CoCrMo heads was observed, neither was there any beneficial reduction in metal ion exposure with the Oxinium femoral heads. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis

Author

Hermansen, Erland, primary, Austevoll, Ivar Magne, additional, Hellum, Christian, additional, Storheim, Kjersti, additional, Myklebust, Tor Åge, additional, Aaen, Jørn, additional, Banitalebi, Hasan, additional, Anvar, Masoud, additional, Rekeland, Frode, additional, Brox, Jens Ivar, additional, Franssen, Eric, additional, Weber, Clemens, additional, Solberg, Tore K., additional, Furunes, Håvard, additional, Grundnes, Oliver, additional, Brisby, Helena, additional, and Indrekvam, Kari, additional

Published
2022
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35. The use of common „instability“ criteria does not seem to improve patient selection for fusion surgery in patients with degenerative spondylolisthesis

Author

Hellum, Christian, Rekeland, Frode, Småstuen, Milada Cvancarova, Hermansen, Erland, Storheim, Kjersti, Brox, Jens Ivar, Indrekvam, Kari, Weber, Clemens, Banitalebi, Hasan, Brisby, Helena, Bøker, Tordis, Grundnes, Oliver, Hector Algaard, Knut Robert, Furunes, Håvard, and Austevoll, Ivar Magne

Published
2022
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36. Comparison of three different minimally invasive surgical techniques for lumbar spinal stenosis (the spinal stenosis trial of the nordsten-study) a pragmatic multicenter randomized trial

Author

Hermansen, Erland, Austevoll, Ivar Magne, Hellum, Christian, Storheim, Kjersti, Aaen, Jørn, Banitalebi, Hasan, Rekeland, Frode, Brox, Jens Ivar, Franssen, Eric, Weber, Clemens, Solberg, Tore, Furunes, Håvard, Grundnes, Oliver, Brisby, Helena, and Indrekvam, Kari

Published
2022
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37. Clinical and MRI findings in lumbar spinal stenosis: baseline data from the NORDSTEN study

Author

Aaen, Jørn, primary, Austevoll, Ivar Magne, additional, Hellum, Christian, additional, Storheim, Kjersti, additional, Myklebust, Tor Åge, additional, Banitalebi, Hasan, additional, Anvar, Masoud, additional, Brox, Jens Ivar, additional, Weber, Clemens, additional, Solberg, Tore, additional, Grundnes, Oliver, additional, Brisby, Helena, additional, Indrekvam, Kari, additional, and Hermansen, Erland, additional

Published
2021
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39. Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis

Author

Austevoll, Ivar M., primary, Hermansen, Erland, additional, Fagerland, Morten W., additional, Storheim, Kjersti, additional, Brox, Jens I., additional, Solberg, Tore, additional, Rekeland, Frode, additional, Franssen, Eric, additional, Weber, Clemens, additional, Brisby, Helena, additional, Grundnes, Oliver, additional, Algaard, Knut R.H., additional, Böker, Tordis, additional, Banitalebi, Hasan, additional, Indrekvam, Kari, additional, and Hellum, Christian, additional

Published
2021
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47. In Vivo strain measurements in rat femur

Author

Husby, Otto Schnell, Indrekvam, Kari, Gjerdet, Nils Roar, Engesaeter, Lars B., and Langeland, Norvald

Abstract

The purpose of the present study was to evaluate strain in the femora of rats during walking. Uni-directional strain gauge units were implanted. Peak strain at the anterior and medial aspects of the rat femur was compressive, while peak strain at the posterior aspect was tensile during walking. Median strain values at the anterior mid-diaphyseal aspect varied between 297x10-6 and 434x10-6. There were no statistical differences between recordings at different times after implantation as evaluated by daily measurements for one week. Neither was there any statistically significant difference in strain values between the walking speeds of 6.0, 10.2, and 14.7 m/min, or between values for right and left femur. In vitro measurements on replaced gauges corresponded within 5 per cent with results from bones where gauges had been implanted for one week. Waterproofing the strain gauge unit with a resin did not significantly affect the measurements. The method, therefore, enables studies of strain behavior of bone from small species in vivo under physiological and pathophysiological conditions., Scandinavian Journal of Laboratory Animal Sciences, Vol. 15 No. 4 (1988)

Published
2019
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48. Decompression alone versusdecompression with instrumental fusionthe NORDSTEN degenerativespondylolisthesis trial (NORDSTEN-DS);study protocol for a randomized controlledtrial

Author

Austevoll, Ivar Magne, Hermansen, Erland, Fagerland, Morten, Rekeland, Frode, Solberg, Tore, Storheim, Kjersti, Brox, Jens Ivar, Lønne, Greger, Indrekvam, Kari, Aaen, Jørn, Grundnes, Oliver, and Hellum, Christian

Subjects
Decompression, Degenerative spondylolisthesis, Fusions, Clinical outcomes, Spinal stenosis, Randomized controlled trials
Abstract

Background Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study.MethodsThe NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10 years.Conclusion The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group. Trial registration ClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018. Helse Vest RHF (the Western Regional Health Authority) has provided funds for the present study.

Published
2018

49. Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial

Author

Austevoll, Ivar Magne, primary, Hermansen, Erland, additional, Fagerland, Morten, additional, Rekeland, Frode, additional, Solberg, Tore, additional, Storheim, Kjersti, additional, Brox, Jens Ivar, additional, Lønne, Greger, additional, Indrekvam, Kari, additional, Aaen, Jørn, additional, Grundnes, Oliver, additional, and Hellum, Christian, additional

Published
2019
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