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Completed

NCT Number: NCT04935281

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous repair with an intraoperative assisted ultrasound

Other

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 assisted ultrasound

Other

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.

Primary outcomes

  1. American Orthopedic Foot and An¬kle Society score

    Time frame: 4 years

    score from 0 to 100 with highest score is better

  2. single leg rising

    Time frame: 3 years

    ability to stand on one leg

  3. magnetic resonance image

    Time frame: one year

    assessment of healing of torn tendon

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2021
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.