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

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ClinicalTrials.gov Identifier: NCT03229369
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : July 26, 2017
Sponsor:
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 : August 2017
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 tunnels will be performed 1cm distal to the articular level, 2cm way from one another, midway from the fibular head and Gerdy Tubercle. 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 tunnels and then retrieved proximal towards the femoral tunnel. ALL is fixed in full extension and neutral rotation. This is a modification of a previously described technique (Sonnery-Cottet 2015).




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 ]
    Lysholm

  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 ]
    Tegner



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

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 ClinicalTrials.gov identifier (NCT number): NCT03229369


Contacts
Contact: Fernando C Rezende, MD (55)1155764848 fernandocuryrezende@gmail.com
Contact: Carlos Eduardo Franciozi, PhD (55)1155764848 cacarlos66@hotmail.com

Locations
Brazil
Federal University of Sao Paulo, Orthopedics and Traumatology Department (UNIFESP-EPM) Recruiting
Sao Paulo, Brazil, 04038-031
Contact: Fernando C Rezende, MD    (55)1155764848    fernandocuryrezende@gmail.com   
Contact: Carlos Eduardo Franziozi, PhD    (55)1155762887    cacarlos66@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Fernando C Rezende, MD research assistant

Publications:

Responsible Party: Fernando Cury Rezende, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03229369     History of Changes
Other Study ID Numbers: Anterolateral ligament trial
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
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:
ACL
ALL
Ligament injury
Reconstruction

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