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

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.

Study Overview

• Status: Unknown
• Conditions: Flexion Contracture Following Total Knee Replacement
• Intervention / Treatment: Drug: placebo; Drug: Botox

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Recruiting
      • Rothman Institute
    • Lankenau, Pennsylvania, United States, 19096
      • Recruiting
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: placebo
Experimental: Botox injection	Drug: Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Range of Motion: knee	1 year

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Collaborators: Sharpe-Strumia Research Foundation

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture
• Other Study ID Numbers: 2012ES01