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

Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?

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

Study Overview

• Status: Completed
• Conditions: Acute Rupture of Achilles Tendon
• Intervention / Treatment: Other: percutaneous repair with an intraoperative assisted ultrasound; Other: percutaneous repair without an intraoperative assisted ultrasound

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 Type: Observational
• Enrollment (Actual): 91

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

a prospective randomized control study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
percutaneous repair with an intraoperative assissted 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.	Other: percutaneous repair with an intraoperative assisted ultrasound; Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .
percutaneous repair without an intraoperative assissted 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	Other: percutaneous repair without an intraoperative assisted ultrasound; For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Samy AM. Intra-operative ultrasound: does it improve the results of percutaneous repair of acute Achilles tendon rupture? Eur J Trauma Emerg Surg. 2022 Oct;48(5):4061-4068. doi: 10.1007/s00068-022-01926-x. Epub 2022 Mar 11.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 19, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: Tanta H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No