Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381563
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2006-09-27
Brief Title:
Knee Bracing for People With Patellofemoral Osteoarthritis
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Bracing in Patellofemoral Osteoarthritis A Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P60AR047785-06 | NIH | None | httpsreporternihgovquickSearch2P60AR047785-06 |
| P60AR047785 | NIH | None | None |