Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction

NCT06505525 | Recruiting DMC

• 1 other identifier: U1111-1297-1650
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

Abstract Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons. One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively, using one graft limb as an extra-articular reinforcement via the anterolateral ligament (ALL) reconstruction, with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts. Objective: To compare, through a prospective and randomized clinical trial, intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft. Methods: 146 patients will be randomized into two groups of 73 patients. Patients included in the study will be evaluated preoperatively and after surgery at 3, 6, 9, 12, and 24 months postoperatively. The primary outcomes will be clinical failure rate and graft rerupture rate. Secondary outcomes will include functional capacity assessed through IKDC, Lysholm KOOS, and Tegner scores, pain using the VAS, as well as stability assessed by digital rolimeter and objective IKDC. Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale. Keywords: Rupture, Anterior Cruciate Ligament, Anterior Cruciate Ligament Reconstruction

Conditions

Anterior Cruciate Ligament Rupture; Ligament Knee Injury

Keywords

Rupture; Anterior Cruciate Ligament; Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (2)

• Clinical failure rate

  Persistence of pivot shift (grade 1 or higher) in more than one postoperative evaluation compared to the contralateral knee, or a grade 2 or higher pivot shift at any postoperative evaluation.

  Minimum 2 years

• Graft rupture rate

  Graft rupture will be defined as a graft tear confirmed by magnetic resonance imaging (MRI) or arthroscopy in the presence of any clinical failure criteria.

  Minimum 2 years

Secondary Outcomes (11)

• Functional capacity 1

  Minimum 2 years

• Functional capacity 2

  Minimum 2 years

• Functional capacity 3

  Minimum 2 years

• Functional capacity 4

  Minimum 2 years

• Stability 1

  Minimum 2 years

Study Arms (2)

Anatomical ACL reconstruction combined with extra-articular reconstruction with ALL

EXPERIMENTAL

Anatomical ACL reconstruction combined with extra-articular reinforcement reconstruction with ALL

Procedure: Extra-articular reconstruction with the Anterolateral Ligament

Isolated intra-articular anatomical ACL reconstruction

ACTIVE COMPARATOR

Isolated intra-articular anatomical ACL reconstruction

Procedure: Extra-articular reconstruction with the Anterolateral Ligament

Interventions

Extra-articular reconstruction with the Anterolateral Ligament PROCEDURE

Anatomical ACL reconstruction combined with extra-articular reconstruction with the Anterolateral Ligament

Anatomical ACL reconstruction combined with extra-articular reconstruction with ALL; Isolated intra-articular anatomical ACL reconstruction

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present one or more risk factors will be included:
• Age (Female 14 years - 25 years and Male 16 years - 25 years);
• Pivot-shift test \> 2;
• Chronic ACL injury (\>12 months);
• Athlete (Tegner Scale ≥ 7);
• Tibial slope \> 12 degrees;
• Recurvatum \> 5 degrees and \< 15 degrees (asymmetric);
• Ligamentous Hypermobility (Beighton Scale \> 5).
• Individuals over 40 years of age will not be included;
• ACL revision;
• PCL injury (grade 2 and 3);
• MCL injury (grade 2 and 3) or (grade 1 with valgus aligned axis);
• CPL injury (grade 2 and 3 according to Fanelli classification);
• Recurrent patellar dislocation;
• Severe chondral lesion (ICRS grade 3 and 4) larger than 1cm2;

You may not qualify if:

• Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that the participant may be simulating a worse health condition than reality in order to receive financial assistance with work leave.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (2)

Sao Paulo Hospital

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Parelheiros Hospital

São Paulo, São Paulo, 04883-290, Brazil

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Rupture

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• MARCOS VINICIUS CREDIDIO

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCOS VINICIUS CREDIDIO

CONTACT

11980629367; mvcredidio@gmail.com

CARLOS EDUARDO DA SILVEIRA FRANCIOZI, PhD

CONTACT

11998447964; cacarlos66@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding after the assignment of patients to their group will be done as follows: * Participants: No blinding. * Investigators: No blinding. * Intervention providers: No blinding. * Data recorders: Partial blinding. * Outcome assessors: No blinding. * Data analysts, statisticians: Blinding. The statistician will only know the group of each patient after the statistical analysis is complete. * Care providers: No blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Federal University of São Paulo

Model Details: Prospective Multicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)