What side effects are associated with this type of intervention?

The most common side effects of Botulinum Toxin A for treating flexion contracture include localized pain at the injection site, transient muscle weakness, and the potential development of neutralizing antibodies that may reduce treatment efficacy. Rare systemic adverse effects can include dry mouth and flu-like symptoms.

What prior FDA approvals exist?

Botulinum Toxin A, commonly known as Botox, has been FDA-approved for various conditions involving muscle spasticity and contractures, such as cerebral palsy and spastic equinus foot. These approvals are based on its mechanism of action, which involves inhibiting acetylcholine release at the neuromuscular junction, leading to muscle relaxation. This treatment is being studied for its potential efficacy in treating knee flexion contracture post-total knee arthroplasty, aiming to improve knee extension when used alongside standard postoperative rehabilitation.

What other types of research exist?

Promising novel alternatives to Botulinum Toxin A for treating flexion contracture include noninvasive neuromodulation therapy, which has shown effectiveness in reducing muscle spasticity, and biomechanical loading devices, such as wearable robots or neuroprostheses, which can help manage contractures by applying external forces or facilitating antagonist muscle contractions.

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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

Must not have

Subject is mentally incompetent or unable to understand what participation in the study entails

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing whether Botox injections can help patients who have trouble straightening their knee after knee replacement surgery. The Botox is used to relax the hamstring muscles, making it easier for patients to extend their knee. This treatment is added to the usual physical therapy and home exercises. Botulinum toxin type A has been evaluated as a new treatment for flexion contractures following total knee arthroplasty, showing promising results in improving knee extension.

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.

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.

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.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I understand what participating in the study involves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2010 Phase 4 trial • 33 Patients • NCT00178646

Foot pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Volume, High Dose

High Volume, High Dose

Low Volume, Low Dose

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum Toxin A works by inhibiting the release of acetylcholine at the neuromuscular junction, leading to muscle relaxation. This is particularly relevant for patients with flexion contracture after total knee arthroplasty, as it can help reduce the excessive muscle tone that prevents full knee extension. Standard treatments also include aggressive physical therapy and the use of extension orthosis (braces), which aim to stretch and lengthen the contracted muscles and tendons. Combining Botulinum Toxin A with these therapies may enhance overall treatment efficacy by directly reducing muscle spasticity and improving the outcomes of physical rehabilitation efforts.