Utilization of a Knee Brace With Extension Swing

Not Applicable

Withdrawn

• Conditions: Osteo Arthritis Knee
• Interventions: Device: Guardian Sport Rehabilitator knee brace

• Registration Number: NCT05179044
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use.

Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-05
• Study Start: 2022-02-07
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guardian knee brace group	Guardian Sport Rehabilitator knee brace	Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace.

Primary Outcome Measures

Name	Time	Method
Change in range of motion following knee replacement surgery	Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)	At each scheduled visit, subjects will be examined to determine their range of motion (ROM) in the affected leg to see the range of motion change from pre-op to post- op.
Change in extensor leg strength	Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)	Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine extensor leg strength on the affected leg.
Change in flexor leg strength	Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)	Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine flexor leg strength on the affected leg.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States