Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound

Completed

• Conditions: Acute Rupture of Achilles Tendon
• Interventions: Other: percutaneous repair with an intraoperative assisted ultrasound; Other: percutaneous repair without an intraoperative assisted ultrasound

• Registration Number: NCT04935281
• Lead Sponsor: Tanta University

Brief Summary

This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Group A included those managed with the assistant of an intra-operative ultrasound. Group B included those done without ultrasound assistant

Detailed Description

A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation. Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle. For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al. This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. The technique of repair was standardized for all patients in both groups. We used the technique described by Maffulli et al

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2020-03
• Study Completion: 2020-12
• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-19
• Last Update Submitted: 2021-06-19
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• age between 18 and 50 years
• acute ( not more than two weeks) closed complete injury
• injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm

Exclusion Criteria

• incomplete injury
• recurrent injury
• associated fracture ankle or foot
• previous history of local corticosteroids injection
• patients with neurovascular problem (e.g. diabetic, autoimmune ...etc), smoking, and alcoholics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
percutaneous repair with an intraoperative assissted ultrasound	percutaneous repair with an intraoperative assisted ultrasound	a radiologist did an intraoperative ultrasound before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon.
percutaneous repair without an intraoperative assissted ultrasound	percutaneous repair without an intraoperative assisted ultrasound	the course of the sural nerve was determined according to the technique described by Blackmon et al .This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon

Primary Outcome Measures

Name	Time	Method
American Orthopedic Foot and An¬kle Society score	4 years	score from 0 to 100 with highest score is better
single leg rising	3 years	ability to stand on one leg
magnetic resonance image	one year	assessment of healing of torn tendon