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Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

NCT02388646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-12

Study results available
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Summary

The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.

Conditions

Interventions

OTHER

Exercise Only

This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.

DEVICE

Brace Only

This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.

OTHER

Bracing + Exercises

This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.

Sponsors & Collaborators

  • Orthopaedic Research Foundation

    lead OTHER

Principal Investigators

  • Frank R Kolisek, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388646 on ClinicalTrials.gov