N/A
N=5
Validation of a Knee Brace for Gonarthrosis
Gonarthrosis
Bottom Line
View on ClinicalTrials.gov: NCT05814471 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Ease of Use Measurement Scale — 4.05; 3.00; 4.05 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cable fastening system and 3d printed straps(14 days) (Device); Velcro straps system(14 days) (Device); Adjustment period(Velcro-14 days) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TOPMED
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Use Measurement Scale |
4.60; 3.45; 3.80 | — |
| PRIMARY Ease of Use Measurement Scale |
4.60; 3.45; 3.80 | — |
| PRIMARY Comfort Measurement Scale |
90; 75; 77.5 | — |
| PRIMARY Comfort Measurement Scale |
90; 75; 77.5 | — |
| PRIMARY Physical Symptoms |
2.0; -0.2 | — |
| PRIMARY Physical Symptoms |
2.0; -0.2 | — |
| PRIMARY Psychological Symptoms |
-7.4; -6.7 | — |
| PRIMARY Psychological Symptoms |
-7.4; -6.7 | — |
Summary
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.
Eligibility Criteria
Inclusion Criteria
- Has worn an ODRA knee brace multiple hours a day during the last 6 months
Exclusion Criteria
- Wounds on the lower body
Data sourced from ClinicalTrials.gov (NCT05814471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.