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Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot

NCT04897100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2024-03-12

No results posted yet for this study

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

  • Club Foot
  • Achilles Tendon Surgery

Interventions

PROCEDURE

Achilles tendon tenotomy

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Sponsors & Collaborators

  • Indus Hospital and Health Network

    lead OTHER

Principal Investigators

  • Mansoor Khan · Indus Hospital and Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-27
Primary Completion
2023-09-02
Completion
2023-12-16

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897100 on ClinicalTrials.gov