Back to resultsBotulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
Primary Purpose
Flexion Contracture Following Total Knee Replacement
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botox
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Flexion Contracture Following Total Knee Replacement
Eligibility 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
Sites / Locations
- Rothman InstituteRecruiting
- Rothman InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botox injection
Control
Arm Description
Outcomes
Primary Outcome Measures
Range of Motion: knee
Secondary Outcome Measures
Full Information
NCT ID
NCT01829087
First Posted
April 8, 2013
Last Updated
December 12, 2013
Sponsor
Rothman Institute Orthopaedics
Collaborators
Sharpe-Strumia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01829087
Brief Title
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
Official Title
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
Sharpe-Strumia Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexion Contracture Following Total Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox injection
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Range of Motion: knee
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Morrison, MS, CCRP
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
Facility Information:
Facility Name
Rothman Institute
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Individual Site Status
Recruiting
Facility Name
Rothman Institute
City
Lankenau
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
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