WithdrawnNot Applicable

Utilization of a Knee Brace With Extension Swing

Stopped: Logistic difficulties and loss of support from bracing company.

United States0Started 2022-02-07

Plain-language summary

The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥18 years of age * Surgical candidates undergoing primary TKA * Surgical candidates with pre-operative flexion contracture of 10 degrees or greater * Patient is willing to cooperate and follow study protocol and visit schedule Exclusion Criteria: * Patient is pregnant * Patient is unable to provide written consent * Patient has psychiatric disorder that precludes safe study participation * Patients with a prior history of surgery in the affected knee * Vulnerable patient populations

What they're measuring

Change in extensor leg strength

Timeframe: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)

Change in flexor leg strength

Timeframe: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)

Change in range of motion following knee replacement surgery

Timeframe: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)

Trial details

NCT IDNCT05179044

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Osteo Arthritis Knee trials