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Levitation 2 Tri-Compartment Offloader (TCO) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week, 3-months
Awards & highlights

Study Summary

This trial is testing whether a new type of knee brace, the Levitation Tri-compartment Offloader (TCO), is more effective than the current standard of care for treating patients with osteoarthritis (OA) in all three compartments of the knee joint.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VAS pain score - chair rise (3 month)
Secondary outcome measures
30 second chair stand test
40m fast-paced walk test
6 minute walk test
+11 more
Other outcome measures
Device usage
Lower Extremity Activity Scale (LEAS) score
Medication usage
+5 more

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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
796 Previous Clinical Trials
874,763 Total Patients Enrolled
14 Trials studying Osteoarthritis
1,038 Patients Enrolled for Osteoarthritis
Bone and Joint Health Strategic Clinical Network (BJH SCN)UNKNOWN
McCaig Institiute of Bone and Joint HealthUNKNOWN
~7 spots leftby Jun 2025
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