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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT04935281

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Rupture of Achilles Tendon	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 Design

Study Type:

Observational

Actual Enrollment :

91 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ahmed m. samy, assisstant professor, Tanta University

ClinicalTrials.gov Identifier:

NCT04935281

Other Study ID Numbers:

Tanta H

First Posted:

Jun 22, 2021

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Jun 22, 2021