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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04897100
Other study ID # IRD_IRB_2020_03_011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 27, 2020
Est. completion date December 16, 2023

Study information

Verified date March 2024
Source Indus Hospital and Health Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date December 16, 2023
Est. primary completion date September 2, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 36 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Achilles tendon tenotomy
Achilles tendon tenotomy during Ponseti treatment for clubfoot

Locations

Country Name City State
Pakistan Indus Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Indus Hospital and Health Network

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dorsiflexion Ankle dorsiflexion measured in degrees 3 months
Secondary Complications Post-op complications due to tenotomy 3 months
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