Clinical Evaluation of the Levitation Knee Brace in Patients with Knee Osteoarthritis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- VAS pain score - chair rise (3 month)
研究概览
简要总结
Osteoarthritis (OA) is a debilitating disease affecting approximately 1/3 of Canadians over the age of 25. Knee OA typically involves at least 2 of 3 compartments in the knee joint. Conservative treatments include knee braces to manage symptoms and improve joint function. Most knee OA braces are designed to offload one knee compartment, but are not usually indicated for multicompartment knee OA. The Levitation Tri-compartment Offloader (TCO) knee brace stores energy during flexion and provides extension assistance to offload all 3 knee compartments. While there is strong preliminary evidence that the TCO can provide pain relief and improved knee function to users, it is critical to determine whether this brace will have similar benefits for patients with multicompartment knee OA. This pilot randomized control trial evaluates the clinical outcomes of using the TCO in comparison to the current conservative standard of care for knee OA patients.
详细描述
Osteoarthritis (OA) is a debilitating musculoskeletal disease affecting approximately 1/3 of Canadians over age 25. The disease is characterized by loss of cartilage in the afflicted joint and can be a major source of pain, disability, and reduced quality of life. The direct cost of OA in Canada was $2.9 billion CAD in 2010 and is expected to rise to $7.6 billion CAD by 2031. Total knee replacement (TKR) is often used to restore mobility, and the risk for expensive and invasive revision surgery is 2-5 times higher in OA patients younger than 65 years. Thus, finding an alternate early treatment intervention is imperative for societal and economic health. It is well established that excess joint loading is associated with symptoms of knee pain. Existing knee OA (KOA) braces are designed to unload part of the joint to help reduce symptoms of pain and enable patients to participate in physical activity. However, because the majority of KOA braces are designed to offload only one tibiofemoral compartment, they are not indicated for most patients who suffer from patellofemoral (PF) or multi-compartment KOA. The Levitation "Tri-Compartment Offloader" (TCO) knee brace developed by Spring Loaded Technology (SLT) was designed to reduce KOA pain by decreasing compressive forces in all three compartments of the knee with a silicone "liquid spring" providing knee extension assist. The design is predicted to lower the tensile forces of the quadriceps pulling on the knee, thereby decreasing internal joint forces in all three knee compartments. Survey evidence suggests the TCO provides pain relief and improved function to long-term wearers with KOA, especially those with involvement of the PF compartment. However, the generalizability of these benefits to a larger group needs to be investigated through a controlled clinical study involving patients with PF or multi-compartment KOA. The TCO brace provides both a proprioceptive effect as well as a mechanical effect. Soft-shell neoprene knee braces (or 'sleeves') have been shown to reduce pain in KOA patients, believed to be a result of improved proprioception. In order to better isolate and understand the mechanical effect of the extension assist mechanism of the TCO brace on patient outcomes, we require an intervention group with a proprioception intervention only, such as a neoprene sleeve, to remove the potentially confounding effect of proprioception on measured outcomes. Preliminary clinical trial priorities, design and outcome measures have been developed based on clinical outcomes of interest relating to KOA. Participation from key stakeholders including patients, healthcare providers, healthcare administrators and brace manufacturers is critical to ensure research priorities and outcomes are relevant and meaningful. This study represents an opportunity to work directly with patients in the research process, and to evaluate the outcomes of adopting a patient-oriented research approach. Therefore, the focus of this project is to (1) strengthen our preliminary clinical trial plan by refining the priorities, design and desired outcomes, and (2) complete and evaluate a pilot clinical trial based on patient and knowledge-user participation in all phases of the project.
The overall research goal is to conduct a clinical evaluation of the TCO knee brace for treating PF or multi-compartment KOA while incorporating patient participation for optimized study design, implementation and analysis of key outcome measures. This goal will be accomplished across 3 objectives (OB) that coincide with 3 distinct project phases, whereby each project phase is dependent on the outcomes of the previous project phases.
Phase 1 (OB1): Review and improve clinical trial objectives, design and methodology.
Phase 2 (OB2): Perform a pilot trial to evaluate the TCO knee brace in 30 study participants.
Phase 3 (OB3): Interpret study results and create a knowledge translation (KT) plan.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes are assessed by a blinded examiner
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patellofemoral of combined patellofemoral and tibiofemoral knee osteoarthritis
- •Kellgren-Lawrence grade ≥ 2 osteoarthritis (moderate-severe) on weight bearing tunnel view x-ray + skyline
- •Experience knee pain that worsens (VAS pain score ≥ 4) with activities such as squatting, rising from seated, and going up and down stairs
- •Experience less pain (VAS pain score) in the contralateral knee than in the affected knee during weight-bearing activities
- •< 7 degrees of varus/valgus knee alignment
- •Knee flexion/extension range of motion from 5-100 degrees minimum
- •Between the ages of 18-80
- •Able to hear and understand study information and instructions in English
- •Must be able to be fit with a Levitation knee brace
排除标准
- •History of arthroplasty or high tibial osteotomy in the affected limb
- •Surgery (excluding arthroscopy) on either lower limb within last 6 months
- •Arthroscopic debridement of the affected knee within last 3 months
- •Received corticosteroid injections in last 3 months
- •Received hyaluronic acid or platelet-rich plasma (PRP) injections in last 6 months
- •History of rheumatoid arthritis
- •Symptomatic disease of the hip, ankle, or foot
- •History of traumatic onset of knee pain
- •A major lower limb injury within the past year requiring physiotherapy or surgery
- •Previous fracture of the tibia or femur of the affected limb
- •History of diabetic neuropathy or peripheral vascular disease
- •Parkinson's or neurodegenerative order that may affect balance / ability to ambulate
- •Use of a non-study provided knee brace on the affected limb over the study period
- •Known allergy or adverse skin reaction to neoprene
- •Open skin wounds present on the leg of the affected side
- •Unable to physically or mentally comply with the wearing of a knee brace
- •Any contraindications for knee bracing
结局指标
主要结局
VAS pain score - chair rise (3 month)
时间窗: Change from baseline to 3-month follow up
Change in VAS pain score from baseline to follow up at 3 months (primary end point). Self-reported knee pain intensity experienced over the last week during rising from a seated position, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable.
次要结局
- Stair climb test(Change from baseline to 3-month follow up)
- 6 minute walk test(Change from baseline to 3-month follow up)
- VAS pain score - chair rise (6 week)(Change from baseline to 6-week follow up)
- 30 second chair stand test(Change from baseline to 3-month follow up)
- Timed up and go test(Change from baseline to 3-month follow up)
- Hamstrings strength(Change from baseline to 3-month follow up)
- VAS pain score - stairs(Change from baseline to 6-week and 3-month follow ups)
- Quadriceps strength(Change from baseline to 3-month follow up)
- EQ-VAS(Change from baseline to 6-week and 3-month follow ups)
- VAS pain score - squatting(Change from baseline to 6-week and 3-month follow ups)
- EQ-5D Health-related quality of life score(Change from baseline to 6-week and 3-month follow ups)
- VAS pain score - walking on incline(Change from baseline to 6-week and 3-month follow ups)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Change from baseline to 6-week and 3-month follow ups)
- 40m fast-paced walk test(Change from baseline to 3-month follow up)