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.

ABSTRACT:

Background

Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold standard blade tenotomy technique.

Methods

We will randomize 244 feet into group A: needle tenotomy or group B: blade tenotomy. Randomization will be done using a bloc

SUBMITTER: Pigeolet M 

PROVIDER: S-EPMC10617068 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature