NCT05717270

Two-layer Suturing of Achilles Tendon Ruptures

Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (estimated)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493). The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial

Detailed description

This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.

Conditions

• Achilles Tendon Rupture

Interventions

Type	Name	Description
PROCEDURE	Two-layered suture repair	The ruptured Achilles tendon will be sutured in two-layer.

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-02-01
• Completion: 2026-02-01
• First posted: 2023-02-08
• Last updated: 2024-09-27

Locations

1 site across 1 country: Denmark