Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot

NCT ID: NCT04897100

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-27
• Study Completion Date: 2023-12-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Achilles tendon tenotomy

Intervention Type: PROCEDURE

Achilles tendon tenotomy during Ponseti treatment for clubfoot

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.

Group Type: ACTIVE_COMPARATOR

Achilles tendon tenotomy

Intervention Type: PROCEDURE

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Interventions

Achilles tendon tenotomy

Achilles tendon tenotomy during Ponseti treatment for clubfoot

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indus Hospital and Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mansoor Khan

Role: PRINCIPAL_INVESTIGATOR

Indus Hospital and Health Network

Locations

Indus Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 37907927 (View on PubMed)

Other Identifiers

IRD_IRB_2020_03_011

Identifier Type: -

Identifier Source: org_study_id