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Clinical Evaluation of the Levitation Knee Brace

NCT05543486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-03-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Levitation 2 Tri-Compartment Offloader (TCO) knee brace

Spring Loaded Technology Levitation 2 Tri-Compartment Offloader (TCO) brace containing proprietary spring technology providing a knee extension assist.

DEVICE

Knee sleeve

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.

Sponsors & Collaborators

  • Bone and Joint Health Strategic Clinical Network (BJH SCN)

    collaborator UNKNOWN

  • McCaig Institiute of Bone and Joint Health

    collaborator UNKNOWN

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU)

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Janet L Ronsky, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2022-09-29
Completion
2022-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543486 on ClinicalTrials.gov