Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076453
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2004-01-22
Brief Title:
A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Clinical Effects of Altered Biomechanics in Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2011-09
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 is a degenerative joint disease and is the most common form of arthritis This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis
Detailed Description:
Osteoarthritis OA is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints Knee OA causes substantial pain suffering and disability as well as enormous economic burden on the patient unfortunately treatment provides relief but not a cure The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief even with recent advances in pain relievers Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA
Although OA is complex and not completely understood disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration one such device is a lateral wedge orthotic shoe insert When worn during weight-bearing activity these inserts have been shown to reduce loading of the medial compartment and may provide pain relief This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA The study will also assess improvements in loading biomechanics of the knee
This is a 3-year study Patients will be randomly assigned to one of two groups the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts There will be 10 study visits during the course of the study Patients will undergo X-rays and bone mineral density testing DEXA and 3 blood collections during the course of the study
Although OA is complex and not completely understood disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration one such device is a lateral wedge orthotic shoe insert When worn during weight-bearing activity these inserts have been shown to reduce loading of the medial compartment and may provide pain relief This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA The study will also assess improvements in loading biomechanics of the knee
This is a 3-year study Patients will be randomly assigned to one of two groups the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts There will be 10 study visits during the course of the study Patients will undergo X-rays and bone mineral density testing DEXA and 3 blood collections during the course of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2P50AR039239-16 | NIH | None | httpsreporternihgovquickSearch2P50AR039239-16 |