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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
First Posted : April 11, 2013
Last Update Posted : December 13, 2013
Sponsor:
Collaborator:
Sharpe-Strumia Research Foundation
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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 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 Intervention/treatment Phase
Flexion Contracture Following Total Knee Replacement Drug: Botox Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Study
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Botox injection Drug: Botox
Placebo Comparator: Control Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Range of Motion: knee [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829087


Contacts
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Contact: Tiffany Morrison, MS, CCRP 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
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United States, Pennsylvania
Rothman Institute Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Rothman Institute Recruiting
Lankenau, Pennsylvania, United States, 19096
Sponsors and Collaborators
Rothman Institute Orthopaedics
Sharpe-Strumia Research Foundation
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01829087    
Other Study ID Numbers: 2012ES01
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases