Trial reportBMC musculoskeletal disorders2018
The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up.
Trial report in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Effect of using knee valgus brace on pain and activity level over different time intervals among patients with medial knee OA: systematic review.BMC musculoskeletal disorders · 2021Pooled it
- Hip and Knee Bracing: Categorization, Treatment Algorithm, and Systematic Review.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2021Pooled it
- Valgus knee bracing may have no long-term effect on pain improvement and functional activity in patients with knee osteoarthritis: a meta-analysis of randomized trials.Journal of orthopaedic surgery and research · 2020Pooled it
- The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial.Prosthetics and orthotics international · 2026Trial
- Impact of a Sensor-Based Platform on the Outcome of Medial Off-Loader Bracing in Individuals With Knee Osteoarthritis: A Pilot Randomized Clinical Trial.American journal of physical medicine & rehabilitation · 2025Trial
- Unloader brace or high tibial osteotomy in the treatment of the young patient with medial knee osteoarthritis: a randomized controlled trial.Acta orthopaedica · 2025Trial
- Effectiveness and user experiences of a valgus brace in patients with knee osteoarthritis: A mixed-method randomised controlled trial.PloS one · 2025Trial
- Knee Bracing for Unicompartmental Osteoarthritis: A Service Evaluation.Musculoskeletal care · 2025Article
- Impact of a Semi-Rigid Knee Orthotic Intervention on Pain, Physical Activity, and Functional Capacity in Patients with Medial Knee Osteoarthritis.Journal of clinical medicine · 2024Article
- Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee.Orthopaedic journal of sports medicine · 2019Article
- Methods for evaluating effects of unloader knee braces on joint health: a review.Biomedical engineering letters · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment of patients with knee osteoarthritis is challenging. Unloader braces have been developed with various success. Unloader One® Knee Brace is light, easily-fitted and shown to be effective by the unloading of the affected compartment. The aim of the study was to assess the clinical outcome of the brace vs. a placebo on patients with knee osteoarthritis.
methodsInitially 150 patients were randomized to receive either the Unloader brace or a control placebo group look-alike brace where the active strips had been removed. The patients were followed up at 6,12,26 and 52 weeks with Knee Society Score (KSS) and Knee injury and Osteoarthritis Outcome Score (KOOS). The reason for dropout was recorded.
resultsA total of 149 patients were included, 74 in the study and 75 in the control group. The mean age was 59.6 vs. 60.2, BMI was 27.5 vs. 26.9, 37% vs. 44% were women in the study vs. control group. Both groups showed improvement in KSS over 52 weeks, with the study group showing higher improvement in mean scores. KSS increased from 64.3 to 84.0 for the study group and from 64.0 to 74.6 for the control group (p = 0.009). The study group improved in KSS function from 67.0 to 78.6 (p < 0.001) and KOOS for knee related symptoms increased/improved from 64.3 to 72.4 (p < 0.001). Activity of daily living increased/improved from 65.3 to 75.2 and Sports/Recreation from 24.6 to 40.2 (p > 0.001) whereas the control group did not show significant improvements in any of the scores. The dropout was higher in the control group, 40 vs. 25.
conclusionsThe brace seems to be more effective and better tolerated than the placebo.
trial registrationThe trial was retrospectively registered with ClinicalTrials.gov ( NCT03454776 ) on March 6th 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.