Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: a randomized trial (BLEND RCT) using the Trials within Cohorts (TwiCs) design.

BACKGROUND: Spinal metastases can lead to unremitting pain and neurological deficits, which substantially impair daily functioning and quality of life. Patients with unstable spinal metastases receive surgical stabilization followed by palliative radiotherapy as soon as wound healing allows. The time between surgery and radiotherapy delays improvement of mobility, radiotherapy-induced pain relief, local tumor control, and restart of systemic oncological therapy. Stereotactic body radiotherapy (SBRT) enables delivery of preoperative high-dose radiotherapy while dose-sparing the surgical field, allowing stabilizing surgery within only hours. Patients may experience earlier recovery of mobility, regression of pain, and return to systemic oncological therapy. The BLEND RCT evaluates the effectiveness of SBRT followed by surgery within 24 h for the treatment of symptomatic, unstable spinal metastases. METHODS: This phase III randomized controlled trial is embedded within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT) cohort. Patients with symptomatic, unstable spinal metastases requiring stabilizing surgery and radiotherapy will be randomized (1:1). The intervention group (n = 50) will be offered same-day SBRT and surgery, which they can accept or refuse. According to the Trial within Cohorts (TwiCs) design, the control group (n = 50) will not be informed and receive standard treatment (surgery followed by conventional radiotherapy after 1-2 weeks when wound healing allows). Baseline characteristics and outcome measures will be captured within PRESENT. The primary outcome is physical functioning (EORTC-QLQ-C15-PAL) 4 weeks after start of treatment. Secondary endpoints include pain response, time until return to systemic oncological therapy, quality of life, local tumor control, and adverse events up to 3 months post-treatment. DISCUSSION: The BLEND RCT evaluates the effect of same-day SBRT and stabilizing surgery for the treatment of symptomatic, unstable spinal metastases compared with standard of care. We expect better functional outcomes, faster pain relief, and continuation of systemic oncological therapy. The TwiCs design enables efficient recruitment within an ongoing cohort, as well as prevention of disappointment bias and drop-out as control patients will not be informed about the trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05575323. Registered on October 11, 2022.

Cast immobilization with and without immobilization of the thumb for nondisplaced and minimally displaced scaphoid waist fractures: a multicenter, randomized, controlled trial.

PURPOSE: The aim of this prospective randomized trial was to test the null hypothesis that there was no difference in the percentage of the fracture line of scaphoid waist fractures that demonstrated bridging bone on computed tomography (CT) 10 weeks after injury between patients treated in a below-elbow cast including or excluding the thumb. METHODS: A total of 62 patients with a CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fracture of the scaphoid were enrolled in a prospective, multicenter, randomized trial comparing treatment in a below-elbow cast including or excluding the thumb. There were 55 waist and 7 distal fractures (owing to a miscommunication at 3 of the centers). We adhered to intention-to-treat principles. The primary outcome was the extent of union on CT performed after 10 weeks of cast treatment, expressed as a percentage of the fracture line that had bridging bone, determined by musculoskeletal radiologists blinded to treatment. Secondary study outcomes included wrist motion; grip strength; the Mayo Modified Wrist Score; the Disabilities of the Arm, Shoulder and Hand score; a visual analog scale for pain; and radiographic union at 6 months after injury. RESULTS: There was a significant difference in the average extent of union on CT at 10 weeks (85% vs 70%) favoring treatment with a cast excluding the thumb. The overall union rate was 98%. The 1 exception was a patient in the thumb immobilization group who elected operative treatment 1 week after enrollment, used crutches, and failed to heal. There were no significant differences between groups for wrist motion; grip strength; Mayo Modified Wrist Score; Disabilities of the Arm, Shoulder, and Hand score; or pain intensity. CONCLUSIONS: Immobilization of the thumb appears unnecessary for CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fractures of the waist of the scaphoid. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.

Predictors of the accuracy of quotation of references in peer-reviewed orthopaedic literature in relation to publications on the scaphoid.

Using inaccurate quotations can propagate misleading information, which might affect the management of patients. The aim of this study was to determine the predictors of quotation inaccuracy in the peer-reviewed orthopaedic literature related to the scaphoid. We randomly selected 100 papers from ten orthopaedic journals. All references were retrieved in full text when available or otherwise excluded. Two observers independently rated all quotations from the selected papers by comparing the claims made by the authors with the data and expressed opinions of the reference source. A statistical analysis determined which article-related factors were predictors of quotation inaccuracy. The mean total inaccuracy rate of the 3840 verified quotes was 7.6%. There was no correlation between the rate of inaccuracy and the impact factor of the journal. Multivariable analysis identified the journal and the type of study (clinical, biomechanical, methodological, case report or review) as important predictors of the total quotation inaccuracy rate. We concluded that inaccurate quotations in the peer-reviewed orthopaedic literature related to the scaphoid were common and slightly more so for certain journals and certain study types. Authors, reviewers and editorial staff play an important role in reducing this inaccuracy.