Clinical trial NCT04935281: Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound
Official title: Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rupture of Achilles Tendon
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a prospective randomized control study

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

Eligibility criteria: 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

Primary outcomes:
measure: American Orthopedic Foot and An¬kle Society score
timeFrame: 4 years
measure: single leg rising
timeFrame: 3 years
measure: magnetic resonance image
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.