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Effects of Extra-articular Reinforcement in Anterior Cruciate Ligament Reconstruction on the clinical and functional status of high-performance athletes

Effects of ACL Reconstruction on the functionality of high-performance athletes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-43j2rh9
Enrollment
Unknown
Registered
2025-04-08
Start date
2025-05-01
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

anterior cruciate ligament injury

Interventions

This is a prospective, randomized, single-blind, three-arm clinical study. Athletes will be randomly allocated to one of the extra-articular reinforcement interventions associated with Anterior Crucia
(B) single-bundle anterolateral ligament reconstruction (N=73)
(C) double-bundle anterolateral ligament reconstruction (N=73). After eligibility criteria verification, randomization will be performed before the first visit, via the website Randomizer.org. The stu

Sponsors

Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad - INTO
Lead Sponsor
Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad - INTO
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Be a federated athlete who has participated in one or more official competitions in the last two years; be between 18 and 45 years old; have an injury to the Anterior Cruciate Ligament – ACL, without compromising other ligament structures of the knee; have not undergone previous surgery on the affected joint; of either sex

Exclusion criteria

Exclusion criteria: Presence of post-surgical infection; inability to or refusal to perform follow-up assessments

Design outcomes

Primary

MeasureTime frame
To evaluate the progression of knee extensor and flexor muscle strength through isokinetic testing, as well as quadriceps muscle quality via ultrasound imaging. These measurements will be obtained 1 day before surgery and at 3, 6, 9, 12, and 24 months postoperatively

Secondary

MeasureTime frame
We anticipate observing varying levels of improvement over time in functionality and quality of life, depending on the type of extra-articular reinforcement used. These outcomes will be assessed through questionnaires (International Knee Documentation Committee – IKDC for functionality; Short-Form 36 Items – SF-36 for quality of life) and functional Tests (Single Hop Test and Y Balance Test for functional performance). All measurements will be collected 1 day before surgery and at 3, 6, 9, 12, and 24 months postoperatively

Countries

Brazil

Contacts

Public ContactThiago de Carvalho

Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad - INTO

prof.thiagolemos@pm.me+55 (21) 2134-5296

Outcome results

None listed

Source: REBEC (via WHO ICTRP)