ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in knee adduction moment during gait
研究概览
简要总结
The aim of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment osteoarthritis. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with osteoarthritis.
详细描述
INTRODUCTION The Enovis ROAM OA outcomes study is a prospective, single-center, crossover study with a subsequent randomized control phase and extended follow-up gait analysis, intended to evaluate the efficacy of the ROAM OA knee brace in subjects with medial knee osteoarthritis (OA).
The purpose of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment OA. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with OA.
1.1 Background Osteoarthritis of the knee significantly impacts the quality of life and functional capacity of those affected. Globally, hundreds of millions of people live with OA, with the knee being the most frequently affected joint. This condition leads to symptoms such as pain, swelling, and stiffness, which impair mobility and daily activities, affecting overall well-being and social connectedness.
The prevalence of knee OA is influenced by factors such as aging and obesity, and with an aging population, the incidence of knee OA is expected to rise. This increase underscores the need for effective management strategies.
Non-invasive interventions such as knee orthoses have been highlighted in OA management. These devices, including the ROAM OA Single Upright Brace, are designed to unload the affected compartment of the knee to reduce pain and improve function. Despite their potential benefits, the efficacy and biomechanical impacts of these braces require further investigation to optimize their clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding; all participants and study team are aware of the assigned brace.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age 40-85 years.
- •Physician-diagnosed medial compartment knee osteoarthritis.
- •Visual Analog Scale (VAS) walking pain ≥
- •Willing to wear assigned brace ≥ 4 hours/day.
- •Able to walk independently for 20 minutes unaided.
- •Stable pain medication regimen ≥ 4 weeks.
- •≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection.
排除标准
- •Lateral or patellofemoral osteoarthritis.
- •Prior knee replacement.
- •Significant ligament injury or acute lower limb injury.
- •Neurological condition affecting gait.
- •Severe psychiatric or neurological disorder affecting pain perception.
- •Skin condition or allergy preventing brace use.
- •Current use of another brace or assistive device.
- •Recent opioid or corticosteroid use (<4 weeks).
- •Pregnant.
- •Exclusion Criteria:
研究组 & 干预措施
ROAM OA brace
Participants receive the ROAM OA Single Upright Knee Brace (Enovis) to wear daily for the study duration. The brace is designed to offload the medial compartment of the knee and improve pain and function.
干预措施: ROAM OA Single Upright Knee Brace (Device)
Active Comparator: Unloader brace or standard of care
Participants receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard pain management and physical therapy guidelines. This group serves as an active comparator to the ROAM OA brace.
干预措施: Ossur Unloader One Knee Brace or Standard of Care (Device)
结局指标
主要结局
Change in knee adduction moment during gait
时间窗: Baseline, 4 weeks, and 8 weeks
Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.
Change in Visual Analog Scale (VAS) walking pain
时间窗: Baseline, 4 weeks, and 8 weeks
Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.
Change in knee adduction moment during gait
时间窗: Baseline, 4 weeks, and 8 weeks
Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.
Change in Visual Analog Scale (VAS) walking pain
时间窗: Baseline, 4 weeks, and 8 weeks
Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.
次要结局
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) subscale scores(Baseline, 4 weeks, and 8 weeks)
- Change in knee range of motion (ROM)(Baseline, 4 weeks, and 8 weeks)
- Change in KOOS (Knee injury and Osteoarthritis Outcome Score) subscale scores(Baseline, 4 weeks, and 8 weeks)
- Change in knee range of motion (ROM)(Baseline, 4 weeks, and 8 weeks)
研究者
Markus Wimmer
Principal Investigator, Grainger Director of the RUSH Arthritis and Orthopedics Institute
Rush University Medical Center