Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes related to pain and function.
详细描述
Patients in this study have been identified as good candidates by their physicians. As the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. The study was designed to present the least risk possible consistent with sound research design.
Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford.
These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No one will be masked/blinded in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anterior knee pain that worsens when the knee is flexed and bearing weight
- •Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
- •Kellgren and Lawrence grade 0-3 of PF joint
- •Able to wear the TCU knee brace for a minimum of 3 hours per day
- •Over 18 years old, can understand written English
- •Coronal knee alignment within 7 degrees of neutral
- •Must be able to fit within an off-the-shelf knee brace size provided by Company
- •Must complete physical therapy through Stanford
排除标准
- •Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
- •Use of another brace designed to unload the knee or manage knee pain during the study
- •Varus/Valgus joint alignment > 7 degrees
- •Inability to be fit properly in an off-the-shelf brace provided by the Company
- •Bilateral knee symptoms
研究组 & 干预措施
No Brace Group
50% of the participants in the study that will not be receiving a TCU brace.
Tri-Compartment Unloader Brace Group
50% of the participants in the study that will be receiving a TCU brace.
干预措施: Tri-Compartment Unloader Brace (Device)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 6-weeks, and 3-months
Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Pain Visual Analog Scale (VAS)
时间窗: Baseline, 6-weeks, and 3-months
Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.
次要结局
- Quadricep Strength (Girth)(Baseline through 3-months post-intervention)
- Effusion Grade(Baseline through 3-months post-intervention)
- Painful Crepitus With Deep Knee Flexion(Baseline through 3 months post-intervention)
- Knee Range of Motion(Baseline through 3 months post-intervention)
- Lower Extremity Activity Scale (LEAS)(Baseline, 6-weeks, and 3-months)
- Quality of Life (EQ-5D)(Baseline, 6-weeks, and 3-months)
- Quadricep Strength (Girth)(Baseline; 6-weeks and 3-months post-intervention)
- Knee Range of Motion(Baseline; 6-weeks and 3-months post-intervention)
- Effusion Grade(Baseline; 6-weeks and 3-months post-intervention)
- Painful Crepitus With Deep Knee Flexion(Baseline; 6-weeks and 3-months post-intervention)
研究者
Seth Sherman
Associate Professor of Orthopaedic Surgery
Stanford University