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A Randomized Controlled Trial Comparing a Patella-Stabilizing, Motion-Restricting Knee Brace Versus a Neoprene
Essi E Honkonen1,2, Petri J Sillanpää2,3, Aleksi Reito1
1Unit of Musculoskeletal Surgery, Department of Orthopaedics, Tampere University Hospital, Tampere, Finland.
Background:
A traumatic lateral patellar dislocation is a common injury in adolescents and young adults. The majority of first-time dislocations can be treated nonoperatively. Various types of knee braces are used for nonoperative treatment, but evidence on the most preferable bracing method is lacking.
Purpose:
To evaluate the efficacy of a patella-stabilizing, motion-restricting knee brace versus a neoprene nonhinged knee brace for the treatment of a first-time traumatic patellar dislocation at 3 years of follow-up.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
A total of 101 skeletally mature patients with a first-time traumatic patellar dislocation were enrolled in the study. After exclusion criteria were applied, 79 patients with a first-time traumatic patellar dislocation were randomized and allocated into 2 study groups: group A, with a patella-stabilizing, motion-restricting knee brace (hinged to allow knee range of motion [ROM] of 0°-30°) and group B, with a neoprene nonhinged knee brace (not restricting any knee motion). Both groups received similar physical therapy instructions and were advised to use the brace continuously for 4 weeks. Overall, 64 patients completed the trial.
Results:
The redislocation rate in group A was 34.4% (11/32) and in group B it was 37.5% (12/32) (risk difference, -3.1% [95% CI, -26.6% to 20.3%]; P = .794). Patients in group A had less knee ROM than those in group B at 4 weeks (90° vs 115°, respectively; P < .001) and 3 months (125° vs 133°, respectively; P = .028). Patients in group A had more quadriceps muscle atrophy than patients in group B at 4 weeks (24/32 vs 16/32, respectively; P = .048) and 3 months. At 6 months, patients in group B reported better functional outcomes than patients in group A (Kujala score mean difference, 4.6; P = .012), although no clinically relevant difference was found at 3 years.
Conclusion:
The use of a patella-stabilizing, motion-restricting knee brace for 4 weeks after a first-time traumatic patellar dislocation did not result in a statistically significant reduction in redislocations versus a neoprene nonhinged knee brace, although this trial was underpowered to detect more modest differences. Knee immobilization was associated with quadriceps muscle atrophy, less knee ROM, and worse functional outcomes in the first 6 months after the injury.
Registration:
NCT01344915 (ClinicalTrials.gov identifier).
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