Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT01829087
Recruitment Status : Unknown
Verified December 2013 by Rothman Institute Orthopaedics. Recruitment status was: Recruiting
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.
Condition or disease
Flexion Contracture Following Total Knee Replacement
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject is at least 18 years of age
Subject had a total knee replacement or total knee replacement revision surgery performed at Main Line hospitals such as Bryn Mawr Hospital, Lankenau Hospital, and Riddle Hospital
Subject is measured to have at least 10 degree flexion contracture of the operative knee four to six weeks following surgery
Subject has the willingness to complete scheduled follow up evaluations as described in the informed consent
Subject is currently involved in another study or has received investigational product or treatment within the last 30 days
Subject is a prisoner
Subject is anticipated to be non-compliant
Subject is known to be pregnant
Subject is mentally incompetent or unable to understand what participation in the study entails
The subject has a known sensitivity or allergic reaction to Botulinum Toxin A and albumin
The subject is unwilling or unable to give consent or to comply with the follow up program