Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

NCT00124462 | Completed Results FDA Device

• 2 other identifiers: H-24147H133G040201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)

  The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

  Baseline and 12 weeks

• Change in WOMAC Function Scale (Most Symptomatic Treated Knee)

  The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.

  Baseline and 12 weeks

Study Arms (2)

Realignment to Placebo

OTHER

Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.

Device: Realigning knee brace and custom orthodic; Device: Non realigning knee brace and flat orthodic

Placebo to Realignment

OTHER

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

Device: Realigning knee brace and custom orthodic; Device: Non realigning knee brace and flat orthodic

Interventions

Realigning knee brace and custom orthodic DEVICE

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

Placebo to Realignment; Realignment to Placebo

Non realigning knee brace and flat orthodic DEVICE

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

Placebo to Realignment; Realignment to Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trial participants must meet American College of Rheumatology (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 the researchers 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. Medial disease is based on definitions used in the researcher's previous publications as definite radiographic OA + at least grade 1 medial narrowing (0-3 scale) using an atlas from the Osteoarthritis Research Society International.

You may not qualify if:

• 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, the researchers 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)
• Bilateral total knee replacements (TKR) or plan for TKR in next 6 months for affected knee.
• Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus erythematosus (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).

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University, School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: ClinicalTrials.gov Administrator
• Organization: Boston Univeristy

damusk@bu.edu

617 638 8862

Study Officials

• David J Hunter

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: July 28, 2005
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)