Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot

Achilles Tendon Surgery Clinical Trial

Official title:

Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897100
• Other study ID #: IRD_IRB_2020_03_011
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Achilles Tendon Surgery
• Club Foot
• Clubfoot

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