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OpenTrials
Completed

NCT Number: NCT04897100

Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Achilles tendon tenotomy

Procedure

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Primary outcomes

  1. Dorsiflexion

    Time frame: 3 months

    Ankle dorsiflexion measured in degrees

Secondary outcomes

  1. Complications

    Time frame: 3 months

    Post-op complications due to tenotomy

Sponsors and collaborators

Lead sponsor

Indus Hospital and Health Network

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 21, 2021
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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