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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Surgery; Club Foot
• Intervention / Treatment: Procedure: Achilles tendon tenotomy

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Indus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Needle tenotomy; Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.	Procedure: Achilles tendon tenotomy; Achilles tendon tenotomy during Ponseti treatment for clubfoot
Active Comparator: Blade tenotomy; Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.	Procedure: Achilles tendon tenotomy; Achilles tendon tenotomy during Ponseti treatment for clubfoot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dorsiflexion	Ankle dorsiflexion measured in degrees	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Post-op complications due to tenotomy	3 months

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network
• Investigators: Principal Investigator: Mansoor Khan, Indus Hospital and Health Network

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Actual): September 2, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Clubfoot
• Other Study ID Numbers: IRD_IRB_2020_03_011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The participant data will be made available in an anonymous manner as a supplement to the final publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No