The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee OA relieves knee pain and improves function. We 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.

Condition	Intervention
Knee Osteoarthritis	Device: Brace and Shoe Insert

Further Study Details: 

Primary Outcomes: WOMAC Pain and Function Subscales (Most symptomatic treated Knee)
Secondary Outcomes: WOMAC Stiffness Subscale; Knee Injury and Osteoarthritis Outcome Score; Patient Global Assessment; Overall Knee Pain V.A.S. (Knee specific); SF36; Analgesic Use (Medication log); Blinded knee exam by physician; Physician Global Assessment; Functional performance measures; Proprioception
Expected Total Enrollment:  80

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Trial participants must meet ACR criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte. In addition, because we are interested in recruiting persons with medial knee osteoarthritis, participants will need to have evidence of disease in this compartment on their radiographs, and not have lateral compartment or patellofemoral compartment disease. We will define medial disease based on definitions used in our previous publications as definite radiographic OA + at least grade 1 medial narrowing (0-3 scale) using atlas from Osteoarthritis Research Society International.

Exclusion Criteria:

• Individuals with clinical evidence of patellofemoral disease or knee pathology (other than medial compartment OA) likely to be causing their knee pain.
• Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.
• Amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. Persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.
• Known neuropathy from diabetes or for other reasons.
• Past history of deep venous thrombosis.
• Pain emanating more from back or hip than from knee as determined by screening questionnaire
• Low pain score on WOMAC, a widely used and well validated questionnaire to assess knee symptoms. To evaluate response, we will require that patients have a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 for the WOMAC pain scale in the eligible knee at pre-randomization phone call and visit, and at randomization visit. This will allow us to detect response to treatment if response occurs.
• Planning to move from area within 9 months of study screening
• Symptomatic comorbid disease limits walking more than knee pain (per screening questionnaire)
• Receiving corticosteroid injections in the month prior to starting the trial. No other treatments will trigger exclusion, although for patients who have been on glucosamine +/or chondroitin +/or NSAID we will require that they must have taken these treatments for at least 2 months prior to onset of trial and to commit to not start a new treatment throughout the trial.
• Bilateral total knee replacements or plan for TKR in next 6 months for affected knee.
• Known other causes of arthritis including RA, SLE, gout, psoriatic arthritis, pseudogout.
• Failure to pass 4 week run-in test.
• Volunteers in a pre-contemplative state (persons who would not consider realignment therapy as a therapeutic option for their knee OA).

Please refer to this study by ClinicalTrials.gov identifier  NCT00124462

Janelle Branch      617.638.5806    jbranch@bu.edu
Paula I McCree      617.638.4305    pmccree@bu.edu

Massachusetts
      Boston University, School of Medicine, Boston,  Massachusetts,  02118,  United States; Recruiting

Study chairs or principal investigators

David J Hunter,  Principal Investigator,  Boston University School of Medicine   

Study ID Numbers:  84.133G-1
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124462
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02