Recruiting

Botulinum Toxin A

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT01829087

Conditions

Flexion Contracture Following Total Knee Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Botox

placebo

Study Details

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.

Conditions

Flexion Contracture Following Total Knee Replacement

Study ID

NCT01829087

Start date

Aug, 2012

Status verified date

Dec, 2013

Primary completion date

Aug, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Botox injection

placebo comparator: Control

Interventions

Botox

placebo

Primary outcome measure

  • Range of Motion: knee [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Tiffany Morrison, MS, CCRP

267-339-7818tiffany.morrison@rothmaninstitute.com

Locations

Rothman Institute

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Rothman Institute

Recruiting

Lankenau, Pennsylvania, United States, 19096

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Dec 13, 2013

Last verified

Dec, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2013-12-13.