Evidence map›Paper›PMID 40514746›Full record

ArticlePilot and feasibility studies2025

A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis.

Emily L Bishop, Justin Bonhomme, Molly Joffe, Chris Cowper-Smith, Janet L Ronsky, Marcia L Clark

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05543486 (Clinical Evaluation of the Levitation Knee Brace in Patients With Knee Osteoarthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05543486 nacompletednot on this map

Clinical Evaluation of the Levitation Knee Brace in Patients With Knee Osteoarthritis: A Pilot Study

TypeinterventionalSponsorUniversity of CalgaryRan2021 to 2022Enrolled26ConditionsKnee OsteoarthritisArmsLevitation 2 Tri-Compartment Offloader (TCO) knee brace, Knee sleeve
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Emily L BishopDepartment of Mechanical and Manufacturing Engineering, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada. elbishop@ucalgary.ca.
Justin BonhommeDepartment of Mechanical and Manufacturing Engineering, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada.
Molly JoffeCumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Chris Cowper-SmithSpring Loaded Technology, Dartmouth, NS, Canada.
Janet L RonskyDepartment of Mechanical and Manufacturing Engineering, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada.
Marcia L ClarkMcCaig Institute for Bone and Joint Health, University of Calgary, Calgary, AB, Canada.

Funding

Bone and Joint Health Strategic Clinical Network Facilitation Funding OpportunityCIHR 425086Cumming School of Medicine, University of Calgary Clinical Research FundMcCaig Institute for Bone and Joint Health Facilitation Funding OpportunityMitacs IT13127
6 · The paper itself

Abstract

backgroundThe Levitation™ "Tri-Compartment Offloader" (TCO) knee brace (Spring Loaded Technology) is designed to reduce pain for individuals with knee osteoarthritis (OA). The TCO is available on the market, however, has not been compared to the current standard of care treatment for knee OA with a controlled clinical trial. This feasibility study aimed to (i) evaluate the feasibility of conducting a full RCT, (ii) evaluate the distributional properties of the Visual Analog Scale (VAS) activity-specific knee pain score to estimate the sample size required for a full randomised controlled trial (RCT), and (iii) refine and optimise the study protocol.

methodsA prospective, 3-group, parallel, single-centre feasibility RCT of individuals with moderate to severe patellofemoral or multicompartment knee OA was undertaken at the University of Calgary (Alberta, Canada). Participants were randomised using a 1:1:1 random allocation to one of three intervention groups: standard of care (Control), Control plus a knee sleeve (Sleeve), or Control plus a TCO brace (TCO). Participants were assessed at baseline (before intervention) and after 6 weeks and 3 months (primary endpoint) of controlled intervention. The sample size for a full RCT was estimated based on the change in VAS knee pain between baseline and 3 months. Feasibility was assessed using participant recruitment, intervention adherence, participant response rates, data quality, dropout rate and adverse events. All protocol changes made throughout the duration of the study were recorded.

resultsTwenty-nine participants (13 females; age: 62 ± 9 years) were recruited. The estimated sample size for a full RCT is 93 individuals (31 per group). Participants showed high intervention adherence and follow-up rates were 86% at 3 months. Four participants dropped out of the study, and there were 3 adverse events reported. Changes were made to participant eligibility criteria, recruitment strategy and data collection methods to improve feasibility, efficiency, and appropriateness for a full RCT.

conclusionsThis study supports the feasibility of a full scale RCT evaluating the clinical effectiveness of the TCO knee brace compared to the current (conservative) standard of care treatment for individuals with knee OA, and an adequately powered RCT is now warranted.

trial registrationClinicalTrials.gov, ID: NCT05543486. Registered 15 September 2022-retrospectively registered, https://clinicaltrials.gov/study/NCT05543486.

Indexed as

BracingKnee osteoarthritisKnee painTri-compartment offloader

Identifiers

PMID40514746
PMCPMC12164062

What Socratic holds

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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.