Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot

NCT04897100 | Completed

• 1 other identifier: IRD_IRB_2020_03_011
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Club Foot; Achilles Tendon Surgery

Outcome Measures

Primary Outcomes (1)

• Dorsiflexion

  Ankle dorsiflexion measured in degrees

  3 months

Secondary Outcomes (1)

• Complications

  3 months

Study Arms (2)

Needle tenotomy

EXPERIMENTAL

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

Blade tenotomy

ACTIVE COMPARATOR

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

Interventions

Achilles tendon tenotomy PROCEDURE

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Blade tenotomy; Needle tenotomy

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Pigeolet M, Ghufran Syed J, Ahmed S, Chinoy MA, Khan MA. A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet-study protocol. Trials. 2023 Oct 31;24(1):701. doi: 10.1186/s13063-023-07728-9.

  PMID: 37907927 DERIVED

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mansoor Khan

  Indus Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: March 27, 2020
• Primary Completion: September 2, 2023
• Study Completion: December 16, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PA (1)