Clinical Trials Directory

Trials / Completed

CompletedNCT04897100

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
244 (actual)
Sponsor
Indus Hospital and Health Network · Academic / Other
Sex
All
Age
36 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAchilles tendon tenotomyAchilles tendon tenotomy during Ponseti treatment for clubfoot

Timeline

Start date
2020-03-27
Primary completion
2023-09-02
Completion
2023-12-16
First posted
2021-05-21
Last updated
2024-03-12

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT04897100. Inclusion in this directory is not an endorsement.