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

ConditionsAnterior Cruciate Ligament RuptureLigament Knee Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorFederal University of São Paulo

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extra-articular reconstruction with the Anterolateral Ligament

    Procedure/Surgery

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

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Anatomical ACL reconstruction combined with extra-articular reconstruction with ALLExperimental treatment 1 intervention
Group B: Isolated intra-articular anatomical ACL reconstructionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Minimum 2 years
2

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.

Time frame
Minimum 2 years

Secondary outcomes

1

Functional capacity 1

Measured through the Subjective Knee Evaluation Form (IKDC) questionnaire

Time frame
Minimum 2 years
2

Functional capacity 2

Measured through the Lysholm questionnaire

Time frame
Minimum 2 years
3

Functional capacity 3

Measured through the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Time frame
Minimum 2 years
4

Functional capacity 4

Measured through the Tegner questionnaire

Time frame
Minimum 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal University of São Paulo

Lead sponsor

Source ClinicalTrials.gov
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