NCT01829087

Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty

Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research project is to evaluate injections of botulinum toxin A (Botox) as the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current treatment for patients who do not achieve full extension of the knee (flexion contracture) after TKA consists of an aggressive physical therapy program, home stretching program, and the use of an extension orthosis (brace). Many patients do not tolerate wearing these braces. This initial project is designed to use injections of Botox as an adjunct to the standard current treatment and evaluate its efficacy. It is our hypothesis that a single injection into the hamstrings in addition to routine postoperative rehabilitation will result in improved knee extension and this improvement in function should endure without further treatment.

Conditions

• Flexion Contracture Following Total Knee Replacement

Interventions

Type	Name	Description
DRUG	Botox
DRUG	placebo

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• First posted: 2013-04-11
• Last updated: 2013-12-13

Locations

2 sites across 1 country: United States