Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
研究概览
简要总结
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.
详细描述
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:
- Fusion Osteoarthritis Knee Brace
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
Two orthopedic surgeons will blindly grade the osteoarthritis and calculate the mechanical axis and knee angles. The two surgeons' measurements will be averaged. One surgeon's measurements will be repeated to determine intra-observer reliability.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Leg-length discrepancy > 2cm.
研究组 & 干预措施
Control Group
This group receives no experimental bracing intervention in the study.
Experimental Group
This group will receive the Breg Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain.
干预措施: Breg Fusion Unloading Brace (Device)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
时间窗: Baseline, 6 month follow-up
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.
次要结局
未报告次要终点