Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05179044
Study type Interventional
Source NYU Langone Health
Contact Daniel Waren
Phone 212-598-6245
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 1, 2022
Completion date July 1, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04040985 - Legion Primary S & E N/A
Recruiting NCT04525950 - Robotized Navigation Compared to Conventional Technique in Total Knee Replacement N/A
Recruiting NCT04320914 - High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis N/A
Completed NCT03886142 - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis N/A
Recruiting NCT04072055 - MOTO Post-marketing Surveillance Study
Withdrawn NCT03271229 - Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee Phase 2
Suspended NCT03847324 - Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty N/A
Recruiting NCT05126485 - Biofeedback Retention in Individuals With AKA Early Phase 1
Active, not recruiting NCT04231318 - Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain Phase 3
Recruiting NCT04956393 - The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study N/A
Recruiting NCT04541342 - Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy N/A
Completed NCT04391842 - Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis Phase 1
Completed NCT03680807 - Power Production in Older Adults With Knee Osteoarthritis
Completed NCT03783455 - Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis N/A
Recruiting NCT05089253 - Effect of Physical Therapy Modalities in Osteoarthritis N/A
Active, not recruiting NCT04536519 - Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis N/A
Not yet recruiting NCT04635176 - Comparing Local Anesthesia With and Without iPACK Block Phase 4
Recruiting NCT04099394 - Pain & Aging: Combined Interventions for Fitness in the Community Study N/A
Recruiting NCT03196011 - Traditional Versus Alternative Alignment in TKR N/A
Recruiting NCT04503512 - Surgical Excision of the Fat Pad N/A