Clinical Evaluation of the Levitation Knee Brace

Launched by UNIVERSITY OF CALGARY · Sep 15, 2022

Keywords

ClinConnect Summary

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 treatm...

Gender

ALL

Eligibility criteria

• 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