Clinical trial NCT05179044: Utilization of a Knee Brace With Extension Swing
Official title: Utilization of a Knee Brace With Extension Swing Assist Peri-operatively to Prevent Flexion Contractures and Improves Quadriceps Strength After Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Morteza Meftah, MD
role: PRINCIPAL_INVESTIGATOR
References: