Utilization of a Knee Brace With Extension Swing

NCT05179044 | Withdrawn DMC FDA Device

• 1 other identifier: 20-00143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (3)

• Change in extensor leg strength

  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.

  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

  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.

  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

  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.

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

Study Arms (2)

Guardian knee brace group

EXPERIMENTAL

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.

Device: Guardian Sport Rehabilitator knee brace

No Guardian brace used group

NO INTERVENTION

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.

Interventions

Guardian Sport Rehabilitator knee brace 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.

Guardian knee brace group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Morteza Meftah, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: February 7, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)