Status:
UNKNOWN
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
Lead Sponsor:
Rothman Institute Orthopaedics
Collaborating Sponsors:
Sharpe-Strumia Research Foundation
Conditions:
Flexion Contracture Following Total Knee Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01829087
Start Date
August 1 2012
Last Update
December 13 2013
Active Locations (2)
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1
Rothman Institute
Bryn Mawr, Pennsylvania, United States, 19010
2
Rothman Institute
Lankenau, Pennsylvania, United States, 19096