Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT02150057
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2014-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy Study of an Unloading Brace for Knee Osteoarthritis
Sponsor:
Andrews Research & Education Foundation
Organization:
Study Overview
Official Title:
Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.
Detailed Description:
This investigation will recruit 72 subjects from the clinical population of the investigators with symptomatic unicompartmental osteoarthritis of the medial compartment of the knee who meet the inclusion criteria of the investigation. Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:
1. Fusion Osteoarthritis Knee Brace
2. No brace group
Inclusion Criteria:
* Age 30-80.
* History of medial unicompartmental knee pain \> 3 months duration (medial compartment only).
* Narrowing of medial joint space \< one half of lateral compartment
* Varus deformity no greater than 80
* Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities.
* Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries.
* Manual dexterity sufficient to perform all tasks required of study participants.
* Willingness to wear the brace a minimum of 4 hours per day.
Exclusion Criteria:
* Arthritides other than osteoarthritis.
* Previous high tibial osteotomy of the affected knee.
* Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy.
* Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb.
* Flexion limitation \> 20 degrees.
* Significant soft tissue compromise preventing long-term brace use.
* Peripheral vascular disease or other neurovascular complaints
1. Fusion Osteoarthritis Knee Brace
2. No brace group
Inclusion Criteria:
* Age 30-80.
* History of medial unicompartmental knee pain \> 3 months duration (medial compartment only).
* Narrowing of medial joint space \< one half of lateral compartment
* Varus deformity no greater than 80
* Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities.
* Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries.
* Manual dexterity sufficient to perform all tasks required of study participants.
* Willingness to wear the brace a minimum of 4 hours per day.
Exclusion Criteria:
* Arthritides other than osteoarthritis.
* Previous high tibial osteotomy of the affected knee.
* Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy.
* Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb.
* Flexion limitation \> 20 degrees.
* Significant soft tissue compromise preventing long-term brace use.
* Peripheral vascular disease or other neurovascular complaints
Study Oversight
Has Oversight DMC:
True
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?: