Randomized Clinical Feasibility Trial: Comparing a Restrictive and Protective Range-of-Motion Brace for the Nonsurgical Management of the Medial Collateral Ligament of the Knee
Bibliographic record
Abstract
OBJECTIVES: (1) Assess medial collateral ligament (MCL) laxity differences in nonoperatively treated acute MCL and anterior cruciate ligament (ACL)-MCL injuries with 2 range of motion (ROM) knee brace settings. (2) Describe knee ROM, brace satisfaction, overall knee score, adherence, pain, quality of life, and knee function. (3) Assess feasibility of larger trial. DESIGN: Prospective, randomized, single-blinded feasibility clinical trial. PARTICIPANTS: Sixty-four adults with acute moderate-to-severe isolated MCL or combined ACL-MCL injuries at the University of Calgary Sport Medicine Centre. INTERVENTION: Random assignment to the protected (0-90 degrees) or restricted (30-90 degrees) brace group. Four weeks of constant brace wearing, followed by daytime wear until 6 weeks. Rehabilitation exercises prescribed from 2 weeks onward. Follow-up for 12 weeks. MAIN OUTCOME MEASURES: Clinical outcomes included side-to-side difference (SSD) MCL laxity (mm) at 30 degrees knee flexion and 0 degree, ROM, patient-reported pain, overall knee ratings, brace satisfaction, daily adherence, international knee documentation committee subjective, and ACL-quality of life (QOL) collected throughout 12 weeks (baseline, 2, 4, 6, 8, and 12 weeks). The outcome assessor was masked to treatment group allocation. RESULTS: At 12 weeks, 73% had <1 mm SSD valgus laxity at 30 degrees knee flexion, with 82% in the restricted group and 67% in the protected group. All patients reported improved pain; none suffered a loss of knee ROM by 12 weeks. The 30 to 90 degrees brace group trended toward better adherence, satisfaction, function, overall knee scores, and QOL. A larger RCT would be feasible but challenging because of sample size needs and slow recruitment. CONCLUSIONS: Favorable outcomes for bracing moderate-to-severe MCL injuries at 30 to 90 degrees for 6 weeks were observed in this feasibility trial.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.010 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.014 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".