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Botox for Flexion Contracture After Knee Surgery

N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether botulinum toxin A injections can improve knee function after total knee arthroplasty (TKA) for patients with flexion contracture.

Who is the study for?
This trial is for adults over 18 who've had knee replacement surgery at Main Line hospitals and have a knee that won't fully straighten out (at least 10 degrees off) 4-6 weeks after. They must be willing to follow up as required. It's not for prisoners, those unlikely to follow the study plan, pregnant women, mentally incompetent individuals, or anyone allergic to Botox or albumin.Check my eligibility
What is being tested?
The study tests if Botox injections help improve the straightening of the knee when added to standard treatments like physical therapy after total knee arthroplasty. Participants will either get Botox or a placebo injection and their progress will be monitored.See study design
What are the potential side effects?
Botox may cause muscle weakness near where it's injected, pain at the injection site, trouble swallowing, upper respiratory infections like colds or flu symptoms, headache, neck pain and eye problems such as drooping eyelids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had knee replacement surgery at a Main Line hospital.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Range of Motion: knee

Side effects data

From 2010 Phase 4 trial • 33 Patients • NCT00178646
8%
Foot pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Volume, High Dose
High Volume, High Dose
Low Volume, Low Dose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Botox injectionExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,438 Total Patients Enrolled
Sharpe-Strumia Research FoundationOTHER
7 Previous Clinical Trials
749 Total Patients Enrolled

Media Library

Botox Clinical Trial Eligibility Overview. Trial Name: NCT01829087 — N/A
Flexion Contracture Research Study Groups: Botox injection, Control
Flexion Contracture Clinical Trial 2023: Botox Highlights & Side Effects. Trial Name: NCT01829087 — N/A
Botox 2023 Treatment Timeline for Medical Study. Trial Name: NCT01829087 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the sample size of this investigation?

"This specific trial is no longer accepting new patients; it was originally posted on the 1st of August 2012 and was last updated in December 2013. If you're interested, there are currently 14 studies actively recruiting for knee replacement arthroplasty procedures and 60 trials involving Botox treatments that are still seeking participants."

Answered by AI

Are there any existing records of trials done with Botox?

"Presently, 60 clinical trials investigating Botox are running concurrently. 20 of these studies have advanced to the third phase and many originate from Farmington Hills in Michigan. Additional research sites exist across 758 different locations."

Answered by AI

What therapeutic uses does Botox have?

"Botox is frequently used to help those with urinary incontinence, yet it can also provide relief from other conditions such as botulism, spinal cord injury and OABs (overactive bladder syndrome)."

Answered by AI

Is this experiment currently open to new participants?

"Per the data available on clinicaltrials.gov, this experiment is not actively enrolling participants at present. Originally posted in August of 2012 and last modified December 2013, no additional candidates are being sought out for this study; however, 74 other trials remain open to enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
2012. "Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01829087.
All > Pennsylvania
~11 spots leftby Apr 2025
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