- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897100
Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus after correction of the adductus deformity. Tenotomy rates ranging from 63-95% after full cycle of castings have been reported in literature. Percutaneous tenotomy is the gold standard, which can usually be performed in an out-patient setting under local anesthesia using a scalpel blade. A complication rate of 2% (mainly neurovascular injury)has been reported in literature, with accidental sectioning of the peroneal artery being the most common. Development of a pseudo-aneurysm after accidental sectioning of the peroneal artery has been reported in a case report; this delayed further clubfoot treatment.
Percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age. This technique use a large-gauge (16-19 G) needle to percutaneously cut the Achilles tendon. Although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique, no major complications have been reported as yet using the needle technique.
We would like to compare the clinical outcomes and complication rates of both techniques, supporting our hypothesis that both techniques are equally safe and have the same success rate.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sadia Ahmed
- Phone Number: +923442182741
- Email: sadia.ahmed@tih.org.pk
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Indus Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Idiopathic clubfoot.
- Age less than or equal to 36 months at the time of tenotomy.
- Enrolled at the Pehla Qadam clinic at The Indus Hospital in Karachi.
- Fully corrected Adductus deformity with residual equinus after a full casting cycle.
- Completing routine follow up for 3 months post tenotomy.
Exclusion Criteria:
- Refusal of parents to enroll child into this study.
- Syndromic clubfoot.
- Previous treatment for clubfoot (surgical or non-surgical) received.
- Underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Needle tenotomy
Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group.
Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.
|
Achilles tendon tenotomy during Ponseti treatment for clubfoot
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Active Comparator: Blade tenotomy
Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group.
Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.
|
Achilles tendon tenotomy during Ponseti treatment for clubfoot
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dorsiflexion
Time Frame: 3 months
|
Ankle dorsiflexion measured in degrees
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 3 months
|
Post-op complications due to tenotomy
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mansoor Khan, Indus Hospital and Health Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRD_IRB_2020_03_011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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