Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty

NCT01829087 | Unknown

• 1 other identifier: 2012ES01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Range of Motion: knee

  1 year

Study Arms (2)

Botox injection

EXPERIMENTAL

Drug: Botox

Control

PLACEBO COMPARATOR

Drug: placebo

Interventions

Botox DRUG

Botox injection

placebo DRUG

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• Sharpe-Strumia Research Foundation: collaborator

Study Sites (2)

Rothman Institute

Bryn Mawr, Pennsylvania, 19010, United States

RECRUITING

Rothman Institute

Lankenau, Pennsylvania, 19096, United States

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Tiffany Morrison, MS, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

US (2)