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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04897100
Enrollment
244
Registered
2021-05-21
Start date
2020-03-27
Completion date
2023-12-16
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Surgery, Club Foot

Brief 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.

Interventions

PROCEDUREAchilles tendon tenotomy

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Sponsors

Indus Hospital and Health Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dorsiflexion3 monthsAnkle dorsiflexion measured in degrees

Secondary

MeasureTime frameDescription
Complications3 monthsPost-op complications due to tenotomy

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026