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Knee Bracing for People With Patellofemoral Osteoarthritis

2014-07-24 14:23:47 | BioPortfolio

Summary

Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint between the kneecap, called the patella, and the thigh bone, called the femur. This study will determine whether wearing a knee brace that realigns the patella over the femur is effective in relieving pain and improving function in adults with knee osteoarthritis.

Description

Bending and straightening at the knee causes the patella to glide along a groove in the femur bone. However, biomechanical imbalances can cause the patella to jump off track, which can lead to pain. Interventions that alter the load distribution across the patellofemoral joint, such as patella taping, may be helpful in alleviating symptoms. Patellar taping has in fact been shown to be effective in the short-term for treating patellofemoral osteoarthritis. But it has not been widely adopted in the clinical setting because it is complicated to administer, difficult to educate the patient about ongoing application, and lacks evidence of long-term efficacy. Also, patients often experience skin irritation from the taping and discomfort when removing the taping. An alternative treatment option is the use of a knee brace that realigns the tracking of the patella. This study will determine whether wearing a patellofemoral realigning knee brace is effective in relieving pain and improving function in adults with knee osteoarthritis.

Participation in this study will last about 3 to 9 months. All eligible participants will wear the same knee brace for a 2-week run-in period during which they will record when they wear the brace and any pain medication used. Next, participants will be randomly assigned to wear one of two knee braces for 6 weeks and a minimum of 4 hours each day. This will be followed by 6 weeks of wearing no knee brace, and then by 6 weeks of wearing whichever knee brace they did not wear during the first 6-week period. There will be a total of nine study visits. The first study visit will screen for eligible participants and will include an interview, knee evaluations, x-rays, and a urine pregnancy test. The second and sixth study visits will include knee evaluations, brace fittings, and instructions on how to correctly wear and adjust the brace. Most of the other study visits will consist primarily of interviews and functional tests. During the first and third 6-week periods, participants will maintain a log to record how long they wear their braces and any pain medication used. Participants will also wear an accelerometer, which will keep track of how many steps they take.

Participants will have the option of continuing in a 6-month follow-up period during which they can wear the brace of their choice. There will be three evaluations that will include questions on how participants are doing with their braces.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Knee Osteoarthritis

Intervention

Patellofemoral realigning knee brace, Non-aligning knee brace

Location

Boston University, School of Medicine
Boston
Massachusetts
United States
02118

Status

Active, not recruiting

Source

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:23:47-0400

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Correction: Measurements agreement between low-cost and high-level handheld 3D scanners to scan the knee for designing a 3D printed knee brace.

[This corrects the article DOI: 10.1371/journal.pone.0190585.].

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Medical and Biotech [MESH] Definitions

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

A region of the lower extremity immediately surrounding and including the KNEE JOINT.

Replacement for a knee joint.

Replacement of the knee joint.

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