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

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ClinicalTrials.gov Identifier: NCT04935281
Recruitment Status : Completed
First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
ahmed m. samy, 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

Condition or disease Intervention/treatment
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

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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 2016
Actual Primary Completion Date : March 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
a prospective randomized control study
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
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Responsible Party: ahmed m. samy, assisstant professor, Tanta University
ClinicalTrials.gov Identifier: NCT04935281    
Other Study ID Numbers: Tanta H
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries