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Comparison of two surgical techniques for treating recent achilles tendon injuries: a clinical study

Comparison of two Surgical techniques of Acute Injury Repair in the Achilles Tendon: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2tyjxf2
Enrollment
Unknown
Registered
2024-12-14
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture

Interventions

This randomized, single-blind clinical trial aims to compare two surgical techniques for repairing acute Achilles tendon injuries: double transverse incision (Group T) and single longitudinal incision

Sponsors

Instituto de Ciências da Saúde da Universidade Federal do Pará - ICS/ UFPA
Lead Sponsor
Hospital Maradei
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 18 to 60 years old; both sexes; closed Achilles tendon injury with up to 21 days of evolution; non insertional Achilles tendon injury

Exclusion criteria

Exclusion criteria: Bilateral injury; history of previous surgery on the lower limb with injury; rerupture; diabetes mellitus; neurovascular disease; immunosuppressive therapy; use of drug from the fluoroquinolone group; patient who does not attend the return appointment; patient who does not follow the rehabilitation protocol

Design outcomes

Primary

MeasureTime frame
To evaluate the improvement in functional capacity using the AOFAS (American Orthopaedic Foot and Ankle Society), EFAS (European Foot and Ankle Society) and ATRS (Achilles Tendon Total Rupture Score) scores at 6 and 12 months postoperatively in order to identify the approach that was most efficient: minimally invasive or open approach.

Secondary

MeasureTime frame
It is expected to find any adverse events resulting from the interventions, verified through the medical evaluation of the patient in the return consultations at 6 and 12 months post-operatively.;Assess the patient's pain using the Visual Analog Scale when assessing the patient during follow-up appointments at 6 and 12 months post-operatively;To assess the patient's quality of life using the SF-12 health-related quality of life questionnaire, in order to measure their satisfaction and quality of life after the procedure in the follow-up consultations at 6 and 12 months post-operatively.;Assess strength and mobility through the heel lift test; in order to measure muscle condition associated with range of motion after the procedure in follow-up appointments at 6 and 12 months post-operatively;Assess the time to return to work activities after the procedure through interviews at follow-up appointments at 6 and 12 months post-operatively;To assess the time to return to sports activities after the procedure through interviews at follow-up appointments at 6 and 12 months post-operatively.

Countries

Brazil

Contacts

Public ContactWagner Sampaio

Hospital Maradei

wagnersampaio_20@hotmail.com+55 (91) 993755255

Outcome results

None listed

Source: REBEC (via WHO ICTRP)