Utilization of a Knee Brace With Extension Swing

NCT ID: NCT05179044

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2023-07-01

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guardian knee brace group

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.

Group Type: EXPERIMENTAL

Guardian Sport Rehabilitator knee brace

Intervention Type: DEVICE

The Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference.

No Guardian brace used group

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 as part of standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guardian Sport Rehabilitator knee brace

The Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morteza Meftah, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-00143

Identifier Type: -

Identifier Source: org_study_id