Clinical Evaluation of the Levitation Knee Brace

Study Overview
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Brief Summary
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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.

Detailed Description
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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. A fourth study objective (OB4) is to evaluate the impact of patient and researcher engagement on the study. This objective will be addressed throughout the duration of the study. Study Milestones (Specific Aims - SA relating to Objectives). SA1.1 Recruit patient partners to form the Patient Advisory Committee (PAC). SA1.2 Plan and conduct a focus group to review clinical trial design and methodology. SA1.3 Summarize and incorporate patient and researcher feedback into the clinical trial design. SA2.1 Recruit pilot study participants and assign into an intervention group. SA2.2 Collect baseline data and 3-month intervention data. SA2.3 Perform statistical data analysis. SA3.1 Plan and conduct a focus group to review study results and solicit ideas for dissemination. SA3.2 Incorporate feedback into interpretation of pilot trial results. SA3.3 Create and implement knowledge dissemination plan. SA4.1 Create framework to evaluate patient and researcher engagement. SA4.2 Implement evaluation tool to evaluate patient and researcher engagement. SA4.3 Analyze and summarize results of engagement evaluation. KOA affects over 14 million individuals in North America. In Canada, the economic burden of OA cost the healthcare system approximately $27.5B in 2010. A significant portion of the economic burden is related to indirect costs from loss of employment, tax dollars, and disability compensation. This is largely driven by a lack of appropriate solutions for KOA patients to maintain independence and mobility. The Levitation TCO knee brace represents a promising new technology for reducing pain and maintaining mobility in patients who have, or are developing KOA. Generating scientific evidence on the effectiveness of the TCO brace will allow patients and healthcare providers to make informed decisions regarding their treatment options for KOA. Involving patients directly in the study design, conduct, interpretation and dissemination activities will increase the relevance and utility of results and the overall impact. If proven effective, this solution will allow patients to continue working and living the lifestyle they enjoy for much longer than they would otherwise. Given the high prevalence of KOA, the TCO brace has the potential to significantly improve quality of life for millions of Canadians, while significantly reducing the economic burden of KOA in Canada and beyond.

Official Title
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Clinical Evaluation of the Levitation Knee Brace in Patients With Knee Osteoarthritis: A Pilot Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Levitation 2 Tri-Compartment Offloader (TCO) knee brace
* Device: Knee sleeve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, parallel arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levitation 2 Tri-Compartment Offloader (TCO) knee brace<br>Participants in this group are sized and fitted for a Levitation 2 TCO brace and instructed to wear the brace on their affected limb for a total of 3 or more hours per day for 3 months. | Device: Levitation 2 Tri-Compartment Offloader (TCO) knee brace<br>* Spring Loaded Technology Levitation 2 Tri-Compartment Offloader (TCO) brace containing proprietary spring technology providing a knee extension assist.<br>|
| Active Comparator: Knee sleeve<br>Participants are provided with a off-the-shelf knee sleeve and instructed to wear the sleeve on their affected limb for a total of 3 or more hours per day for 3 months. | Device: Knee sleeve<br>* Neenca soft knee sleeve comprised of elastic air knit fabric with a silicone padded patella inset and flexible stays on the medial and lateral sides.<br>|
| No Intervention: Standard of Care Self-Management<br>Control group practicing conservative self-management of knee osteoarthritis without using a knee device (e.g., hard brace or sleeve) for 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score - chair rise (3 month) | 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. | Change from baseline to 3-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score - squatting | Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months. Self-reported knee pain intensity experienced over the last week during squatting, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable. | Change from baseline to 6-week and 3-month follow ups | 
| VAS pain score - stairs | Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months. Self-reported knee pain intensity experienced over the last week during stairs, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable. | Change from baseline to 6-week and 3-month follow ups | 
| VAS pain score - walking on incline | Change in VAS pain score from baseline to follow ups at 6 weeks and 3 months. Self-reported knee pain intensity experienced over the last week during walking on an incline, measured using a 0-100 mm visual analogue scale (VAS), where 0 mm represents no pain and 100 mm represents the worst pain imaginable. | Change from baseline to 6-week and 3-month follow ups | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change in KOOS from baseline to follow ups at 6 weeks and 3 months. Knee Injury and Osteoarthritis Outcome Score (KOOS) encompasses 42-tiems (question) across 5 sub-scales: Pain (9 items); Symptoms (7 items); Activities of Daily Living Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Each item uses a Likert scale with five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Change from baseline to 6-week and 3-month follow ups | 
| EQ-5D Health-related quality of life score | Change in EQ-5D health-related quality of life score from baseline to follow ups at 6 weeks and 3 months. Health related quality of life score is collected using the 5-item descriptive system of the EQ-5D questionnaire covering five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The level (score) for the five dimensions is combined into a 5-digit number that describes the patient's health state. | Change from baseline to 6-week and 3-month follow ups | 
| 30 second chair stand test | Change in 30 second chair stand test score from baseline to follow up at 3 months. The maximum number of sit to stand repetitions from a stationary chair (seat height = 44 cm) that can be completed in 30 seconds. | Change from baseline to 3-month follow up | 
| 40m fast-paced walk test | Change in 40m fast-paced walk test score from baseline to follow up at 3 months. The amount of time in seconds it taken to walk a 40 meters along a 10 meter long gait platform, moving as quickly as without running. | Change from baseline to 3-month follow up | 
| Stair climb test | Change in stair climb test score from baseline to follow up at 3 months. The amount of time in seconds to ascend and immediately descend a 5-step staircase (step height = 19 cm) as quickly as possible without running or skipping steps. | Change from baseline to 3-month follow up | 
| Timed up and go test | Change in stair climb test score from baseline to follow up at 3 months. The amount of time in seconds taken to rise from a stationary chair, walk 3 meters forward, turn, walk 3 meters back to the chair, and sit back down in the chair, moving as quickly as possible without running. | Change from baseline to 3-month follow up | 
| 6 minute walk test | Change in 6 minute walk test score from baseline to follow up at 3 months. The maximum amount of distance in meters that can be walked in 6 minutes along a 10 meter gait platform, moving as quickly as possible without running. | Change from baseline to 3-month follow up | 
| Quadriceps strength | Change in quadriceps strength from baseline to follow up at 3 months. Quadriceps strength refers to maximal voluntary isometric contraction the quadriceps muscles at 45 degrees of knee bend measured in Newton meters (Nm) using a Biodex Medical Systems dynamometer. Quadriceps strength score is recorded as average peak torque in Nm across 3 maximal quadriceps contractions lasting 3 seconds with a 1 minute rest between contractions. | Change from baseline to 3-month follow up | 
| Hamstrings strength | Change in hamstrings strength from baseline to follow up at 3 months. Hamstrings strength refers to the maximal voluntary isometric contraction of the hamstrings muscles at 15 degrees of knee bend measured as peak torque in Newton meters (Nm) using a Biodex Medical Systems dynamometer. Hamstrings strength score is recorded as average peak torque in Nm across 3 maximal hamstrings contractions lasting 3 seconds with a 1 minute rest between contractions. | Change from baseline to 3-month follow up | 
| EQ-VAS | Change in EQ-VAS score from baseline to follow ups at 6 weeks and 3 months. The EQ VAS records self-rated health on a 0-100 vertical visual analogue scale (VAS), where 0 is labelled as The worst health you can imagine and 100 is labelled as The best health you can imagine. | Change from baseline to 6-week and 3-month follow ups | 
| VAS pain score - chair rise (6 week) | Change in VAS pain score from baseline to follow up at 6 weeks. 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. | Change from baseline to 6-week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Osteoarthritis, Brace, Pain