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Background: There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated., Methods/design: This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n = 10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18 years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score ≥ 16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18 months., Discussion: The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery., Trial Registration: Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311 .

Background: Early detection of psychosocial problems post-injury may prevent them from becoming chronic. Currently, there is no psychosocial screening instrument that can be used in patients surviving a physical trauma or injury. Therefore, we recently developed a psychosocial screening instrument for adult physical trauma patients, the PSIT. The aim of this study was to finalize and psychometrically examine the PSIT., Methods: All adult (≥ 18 years) trauma patients admitted to a Dutch level I trauma center from October 2016 through September 2017 without severe cognitive disorders (n = 1448) received the PSIT, Impact of Events Scale-Revised (IES-R), Patient Health Questionnaire-9 (PHQ-9), Rosenberg Self-Esteem Scale (RSES), State-Trait Anxiety Inventory-State (STAI-S), and the World Health Organization Quality of Life-Abbreviated version (WHOQOL-Bref). After 2 weeks, a subgroup of responding participants received the PSIT a second time. The internal structure (principal components analysis, PCA; and confirmatory factor analysis, CFA), internal consistency (Cronbach's alpha, α), test-retest reliability (Intraclass Correlation Coefficient, ICC), construct validity (Spearman's rho correlations), diagnostic accuracy (Area Under the Curve, AUC), and potential cut-off values (sensitivity and specificity) were examined., Results: A total of 364 (25.1%) patients participated, of whom 128 completed the PSIT again after 19.5 ± 6.8 days. Test-retest reliability was good (ICC = 0.86). Based on PCA, five items were removed because of cross-loadings ≥ 0.3. Three subscales were identified: (1) Negative affect (7 items; α = 0.91; AUC = 0.92); (2) Anxiety and Post-Traumatic Stress Symptoms (4 items; α = 0.77; AUC = 0.88); and (3) Social and self-image (4 items; α = 0.79; AUC = 0.92). CFA supported this structure (comparative fit index = 0.96; root mean square error of approximation = 0.06; standardized rood mean square residual = 0.04). Four of the five a priori formulated hypotheses regarding construct validity were confirmed. The following cut-off values represent maximum sensitivity and specificity: 7 on subscale 1 (89.6% and 83.4%), 3 on subscale 2 (94.4% and 90.3%), and 4 on subscale 3 (85.7% and 90.7%)., Conclusion: The final PSIT has good psychometric properties in adult trauma patients.

Background: Proximal femoral fractures are strongly associated with morbidity and mortality in elderly patients. Mortality is highest among frail institutionalized elderly with both physical and cognitive comorbidities who consequently have a limited life expectancy. Evidence based guidelines on whether or not to operate on these patients in the case of a proximal femoral fracture are lacking. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life as operative treatment. This study aims to determine the effect of nonoperative management versus operative management of proximal femoral fractures in a selected group of frail institutionalized elderly on the quality of life, level of pain, rate of complications, time to death, satisfaction of the patient (or proxy) and the caregiver with the management strategy, and health care consumption., Methods: This is a multicenter, observational cohort study. Frail institutionalized elderly (70 years or older with a body mass index < 18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an American Society of Anesthesiologists score of 4 or 5), who sustained a proximal femoral fracture are eligible to participate. Patients with a pathological or periprosthetic fractures and known metastatic oncological disease will be excluded. Treatment decision will be reached following a structured shared decision process. The primary outcome is quality of life (Euro-QoL; EQ-5D-5 L). Secondary outcome measures are quality of life measured with the QUALIDEM, pain level (PACSLAC), pain medication use, treatment satisfaction of patient (or proxy) and caregivers, quality of dying (QODD), time to death, and direct medical costs. A cost-utility and cost-effectiveness analysis will be done, using the EQ-5D utility score and QUALIDEM score, respectively. Non-inferiority of nonoperative treatment is assumed with a limit of 0.15 on the EQ-5D score. Data will be acquired at 7, 14, and 30 days and at 3 and 6 months after trauma., Discussion: The results of this study will provide insight into the true value of nonoperative treatment of proximal femoral fractures in frail elderly with a limited life expectancy. The results may be used for updating (inter)national treatment guidelines., Trial Registration: The study is registered at the Netherlands Trial Register (NTR7245; date 10-06-2018).

Background: If conservative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS(R) gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the attachment of the fascia to the os calcis might induce a healing rate., Methods and Design: A randomized controlled multi centre trial will be performed. The study population consists of 120 patients of 18 years and older. Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4,8,12,26 weeks and 1 year after the procedure.The main outcome measures of this study are pain and function measured with questionnaires., Conclusion: Recent literature show positive effects for the treatment of tendinosis with autologous platelet injections. The forthcoming trial will compare treatment for chronic plantar fasciitis with a steroid injection versus an autologous platelet injection. Our results will be published as soon as they become available., Trial Registration Number: http://www.clinicaltrials.gov NCT00758641.

Background: A discussion is ongoing whether displaced femoral neck fractures in elderly patients should be treated with a non-cemented or a cemented hemiarthroplasty. A recent Cochrane analysis stresses the importance of further research into the relative merits of these techniques. We hypothesise that non-cemented hemiarthroplasty will result in at least the same technical-functional outcome and complication rate, with a shorter operation time., Methods and Design: A randomised controlled multicentre trial will be performed.The study population consists of 200 patients of 70 years and older. Patients with a displaced femoral neck fracture will be allocated randomly to have a cemented or a non-cemented hemiarthroplasty. Data will be collected preoperatively, immediately postoperatively, and 6 weeks, 3 months and 1 year postoperatively.The main outcome measures of this study are technical-functional results of the hemiarthroplasty, duration of surgery, complications, and mid-thigh pain. Secondary outcome measures are living conditions at final follow up, self-reported health-related quality of life, and radiological evaluation of the hemiarthroplasty., Conclusion: A recent Cochrane analysis did not find arguments in favour of either non-cemented or cemented hemiarthroplasty. The forthcoming trial will compare treatment for a displaced femoral neck fracture by cemented versus non-cemented hemiarthroplasty. Our results will be published as soon as they become available., Trial Registration: Trial Registration Number NTR1508.