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Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

NCT00124462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-29

Study results available
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Summary

The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA.

The specific aims are:

* To undertake a 30 week randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment;
* To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by DonJoy Orthopedic, a knee bracing company.

Conditions

Interventions

DEVICE

Realigning knee brace and custom orthodic

A valgus brace, customized functional orthotic for neutral foot position and motion control footwear

DEVICE

Non realigning knee brace and flat orthodic

A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • David J Hunter · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-11-30
Completion
2008-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT00124462 on ClinicalTrials.gov