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Knee Brace for Osteoarthritis

N/A

Waitlist Available

Led By Janet L Ronsky, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

< 7 degrees of varus/valgus knee alignment

Knee flexion/extension range of motion from 5-100 degrees minimum

Must not have

History of arthroplasty or high tibial osteotomy in the affected limb

A major lower limb injury within the past year requiring physiotherapy or surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-week, 3-months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new knee brace called the Levitation Tri-compartment Offloader (TCO) for people with knee osteoarthritis affecting multiple parts of their knee. The brace helps by storing energy when the knee bends and using it to assist in straightening the knee, reducing pain and improving function. The study aims to see if this brace is more effective than current treatments.

Who is the study for?

This trial is for Canadian adults aged 18-80 with moderate to severe knee osteoarthritis, experiencing pain during activities like squatting or climbing stairs. Eligible participants must have less pain in one knee compared to the other and a specific range of knee movement. They should understand English and be able to wear the Levitation brace.

What is being tested?

The study compares the Levitation Tri-compartment Offloader (TCO) knee brace, designed to offload all three compartments of the knee joint, against standard care which includes regular knee sleeves. The goal is to see if TCO can better relieve pain and improve function in patients with multi-compartmental osteoarthritis.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device, skin irritation under where the brace fits, or an increase in joint pain if not properly adjusted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee alignment is less than 7 degrees off straight.

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My knee can bend and straighten between 5 and 100 degrees.

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I am between 18 and 80 years old.

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I have moderate to severe knee arthritis confirmed by an X-ray.

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My knee pain gets worse with activities like squatting or using stairs.

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My other knee hurts less than the one with issues when I put weight on it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had joint replacement or bone surgery in the limb with issues.

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I had a serious leg injury in the last year that needed surgery or physiotherapy.

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I have a history of rheumatoid arthritis.

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I have not had surgery on my legs in the past 6 months, except for arthroscopy.

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I had a knee clean-up surgery within the last 3 months.

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I have received corticosteroid injections in the last 3 months.

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I have had hyaluronic acid or PRP injections in the past 6 months.

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I have pain or discomfort in my hip, ankle, or foot.

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I have had a fracture in the leg that now has cancer.

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I have had diabetic neuropathy or peripheral vascular disease.

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I cannot wear a knee brace due to physical or mental reasons.

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I have Parkinson's or a similar condition affecting my balance or walking.

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I will use my own knee brace during the study.

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I have open skin wounds on the leg of the side affected by my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-week, 3-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-week, 3-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week, 3-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VAS pain score - chair rise (3 month)

Secondary study objectives

30 second chair stand test

40m fast-paced walk test

6 minute walk test

+11 more

Other study objectives

Device usage

Lower Extremity Activity Scale (LEAS) score

Medication usage

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Levitation 2 Tri-Compartment Offloader (TCO) knee braceExperimental Treatment1 Intervention

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.

Group II: Knee sleeveActive Control1 Intervention

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.

Group III: Standard of Care Self-ManagementActive Control1 Intervention

Control group practicing conservative self-management of knee osteoarthritis without using a knee device (e.g., hard brace or sleeve) for 3 months.

0 / 20Eligibility criteria met