Association of ALL and ACL Reconstruction Versus Isolated ACL Reconstruction in High-risk Population: a RCT.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03229369
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
Fernando Cury Rezende, Federal University of São Paulo

Brief Summary:

Persistent rotational instability after standard ACL reconstruction have been extensively described, and it has been shown to keep straight correlation with worse outcomes post-operatively (Chouliaras 2007, Kocher 2004). Anterolateral ligament (ALL) injury have been shown to play a relevant role in the genesis of rotational instability of the knee (Claes 2013, Helito 2013). Many anatomical publications have defined the ALL as a distinct ligament (Claes 2013). Meanwhile, some authors have proposed the association of ACL and ALL reconstruction in selected ACL-deficient individuals to further enhance knee stability postoperatively (Sonnery-Cottet 2015, Dodds 2014). Lack of consensus still predominates among ACL experts regarding the reliability of the combined ACL and ALL considering the controversy that involves both ALL anatomy and biomechanics (Guenther D 2016, Kittl C 2016). Clinical trials with high level of evidence and long term follow-up may be useful in order to determine the reliability of the combined procedure in the clinical setting.

So, the present study aims to compare the effectiveness of the combined ACL and ALL reconstruction with isolated ACL reconstruction in individuals with high-risk of ACL re-rupture, through a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Ligament Knee Injury Procedure: Isolated anatomic ACL reconstruction Procedure: Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Surgeons and participants of the study will not be blinded due to the intrinsic characteristics of the intervention trials, in which it is impossible to blind surgeons and avoid acknowledgement of the participants of which procedure they were assigned. However, outcome evaluation will be performed by an individual who will not have acknowledgement of which group the patient was allocated.
Primary Purpose: Treatment
Official Title: Association of Anterolateral Ligament and Anterior Cruciate Ligament Reconstruction Lead to Superior Outcomes and Lower Failure Rates in High-risk Population?: a Randomized Controlled Trial.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Isolated ACL
Standard Anterior Cruciate Ligament Reconstruction only
Procedure: Isolated anatomic ACL reconstruction
Hamstrings free grafts using a two-incision intra-articular Anterior Cruciate ligament (ACL) reconstruction technique. Both ST and gracilis will be prepared with doubled strands, a standard quadrupled graft. The femoral tunnel will be performed in outside-in manner. The tibial tunnel will be drilled in the center of the ACL tibial footprint, sparing the ACL tibial stump, when possible. ACL graft will be first fixed in the femur and then in the tibia, both with an interference screw at 30 degrees of knee flexion.

Experimental: Combined ACL and ALL
Anterior Cruciate Ligament Reconstruction associated with Anterolateral Ligament Reconstruction
Procedure: Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction
Hamstrings free grafts using a two-incision ACL reconstruction with the addition of a gracilis prolongation for ALL reconstruction. ACL graft will exhibit a quadruple strand (tripled ST + single gracilis) and the ALL graft, a single strand with the gracilis prolongation. ALL tibial tunnel will be performed with a 5mm drill, 1cm distal to the articular level, midway from the fibular head and Gerdy Tubercle, crossing the tibia toward its anteromedial cortex, 1cm distal to the ACL tunnel. Femoral ACL and ALL tunnels are coincident and located posterior and proximal to the lateral epicondyle. Intra-articular surgery will be performed in the same manner as comparative group. Gracilis prolongation is routed through the tibial ALL tunnel and then retrieved in the anteromedial aspect of the tibia, 1cm distal to the ACL tunnel entrance. ALL is fixed in full extension and neutral rotation, tying both graft extremities with 3 knots.

Primary Outcome Measures :
  1. IKDC subjective part for functional outcome [ Time Frame: 24 months ]
    International Knee Documentation Committee

  2. Lysholm for functional outcome [ Time Frame: 24 months ]

  3. KOOS for functional outcome [ Time Frame: 24 months ]
    Knee injury and Osteoarthritis Outcome Score

  4. Knee stability (subjective measures) [ Time Frame: 24 months ]
    Lachman and pivot shift tests

  5. Knee stability (objective measure) [ Time Frame: 24 months ]
    Differential laxity (Rolimeter)

Secondary Outcome Measures :
  1. Re-rupture [ Time Frame: 24 months ]
    Presence of instability and pathological laxity postoperatively needing ACL revision (Middleton KK 2014).

  2. Pain [ Time Frame: 24 months ]
    Visual Analogue Scale (VAS)

  3. Activity Level [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Grade 2 or 3 pivot shift test
  • Chronic ACL lesions (>or= 1 year after lesion)

Exclusion Criteria:

  • Previous knee surgeries
  • Chondral grade IV knee lesions
  • Concomitant knee ligament injuries, other than ACL and ALL ligaments
  • Knee osteoarthritis
  • Semitendinosus graft length shorter than 24mm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03229369

Contact: Fernando C Rezende, MD (55)1155764848
Contact: Carlos Eduardo Franciozi, PhD (55)1155764848

Federal University of Sao Paulo, Orthopedics and Traumatology Department (UNIFESP-EPM) Recruiting
Sao Paulo, Brazil, 04038-031
Contact: Fernando C Rezende, MD    (55)1155764848   
Contact: Carlos Eduardo Franziozi, PhD    (55)1155762887   
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Fernando C Rezende, MD research assistant


Responsible Party: Fernando Cury Rezende, Principal Investigator, Federal University of São Paulo Identifier: NCT03229369     History of Changes
Other Study ID Numbers: Anterolateral ligament trial
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No IPD plan established yet.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fernando Cury Rezende, Federal University of São Paulo:
Ligament injury

Additional relevant MeSH terms:
Knee Injuries
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Leg Injuries