N/A N=51 Randomized Single-blind Prevention

Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Osteoarthritis of the Knee

Bottom Line

View on ClinicalTrials.gov: NCT02150057 ↗

Enrolled (actual)

Serious AEs

4.9%

Results posted

Oct 2019

Primary outcome: Primary: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score — 2.92; 2.86; 3.03; 2.67 units on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Breg Fusion Unloading Brace (Device)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Andrews Research & Education Foundation
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score	2.92; 2.86; 3.03; 2.67	<0.05 sig

Summary

Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.

Eligibility Criteria

Inclusion Criteria

Age 30-80.
History of medial unicompartmental knee pain > 3 months duration (medial compartment only).
Narrowing of medial joint space 10 degrees as compared to the contralateral limb.
Flexion limitation > 20 degrees.
Significant soft tissue compromise preventing long-term brace use.
Peripheral vascular disease or other neurovascular complaints.
Leg-length discrepancy > 2cm.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02150057). 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.