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

NCT03229369 | Unknown

• 1 other identifier: Anterolateral ligament trial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture; Ligament Knee Injury

Keywords

ACL; ALL; Ligament injury; Reconstruction

Outcome Measures

Primary Outcomes (5)

• IKDC subjective part for functional outcome

  International Knee Documentation Committee

  24 months

• Lysholm for functional outcome

  Lysholm

  24 months

• KOOS for functional outcome

  Knee injury and Osteoarthritis Outcome Score

  24 months

• Knee stability (subjective measures)

  Lachman and pivot shift tests

  24 months

• Knee stability (objective measure)

  Differential laxity (Rolimeter)

  24 months

Secondary Outcomes (3)

• Re-rupture

  24 months

• Pain

  24 months

• Activity Level

  24 months

Study Arms (2)

Isolated ACL

ACTIVE COMPARATOR

Standard Anterior Cruciate Ligament Reconstruction only

Procedure: Isolated anatomic ACL reconstruction

Combined ACL and ALL

EXPERIMENTAL

Anterior Cruciate Ligament Reconstruction associated with Anterolateral Ligament Reconstruction

Procedure: Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction

Interventions

Isolated anatomic ACL reconstruction PROCEDURE

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.

Isolated ACL

Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction PROCEDURE

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.

Combined ACL and ALL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo, Orthopedics and Traumatology Department (UNIFESP-EPM)

São Paulo, 04038-031, Brazil

RECRUITING

Related Publications (20)

• Anderson AF, Snyder RB, Lipscomb AB Jr. Anterior cruciate ligament reconstruction. A prospective randomized study of three surgical methods. Am J Sports Med. 2001 May-Jun;29(3):272-9. doi: 10.1177/03635465010290030201.

  PMID: 11394593 BACKGROUND

• Chouliaras V, Ristanis S, Moraiti C, Stergiou N, Georgoulis AD. Effectiveness of reconstruction of the anterior cruciate ligament with quadrupled hamstrings and bone-patellar tendon-bone autografts: an in vivo study comparing tibial internal-external rotation. Am J Sports Med. 2007 Feb;35(2):189-96. doi: 10.1177/0363546506296040. Epub 2007 Jan 23.

  PMID: 17251174 BACKGROUND

• Claes S, Vereecke E, Maes M, Victor J, Verdonk P, Bellemans J. Anatomy of the anterolateral ligament of the knee. J Anat. 2013 Oct;223(4):321-8. doi: 10.1111/joa.12087. Epub 2013 Aug 1.

  PMID: 23906341 BACKGROUND

• Dodds AL, Halewood C, Gupte CM, Williams A, Amis AA. The anterolateral ligament: Anatomy, length changes and association with the Segond fracture. Bone Joint J. 2014 Mar;96-B(3):325-31. doi: 10.1302/0301-620X.96B3.33033.

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  PMID: 1254620 BACKGROUND

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  PMID: 26657572 BACKGROUND

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  PMID: 15090377 BACKGROUND

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  PMID: 15150047 BACKGROUND

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  PMID: 19193599 BACKGROUND

• Monaco E, Ferretti A, Labianca L, Maestri B, Speranza A, Kelly MJ, D'Arrigo C. Navigated knee kinematics after cutting of the ACL and its secondary restraint. Knee Surg Sports Traumatol Arthrosc. 2012 May;20(5):870-7. doi: 10.1007/s00167-011-1640-8. Epub 2011 Aug 30.

  PMID: 21877296 BACKGROUND

• Rezende FC, de Moraes VY, Martimbianco AL, Luzo MV, da Silveira Franciozi CE, Belloti JC. Does Combined Intra- and Extraarticular ACL Reconstruction Improve Function and Stability? A Meta-analysis. Clin Orthop Relat Res. 2015 Aug;473(8):2609-18. doi: 10.1007/s11999-015-4285-y. Epub 2015 Apr 7.

  PMID: 25845949 BACKGROUND

• Ristanis S, Stergiou N, Patras K, Vasiliadis HS, Giakas G, Georgoulis AD. Excessive tibial rotation during high-demand activities is not restored by anterior cruciate ligament reconstruction. Arthroscopy. 2005 Nov;21(11):1323-9. doi: 10.1016/j.arthro.2005.08.032.

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• Schon JM, Moatshe G, Brady AW, Serra Cruz R, Chahla J, Dornan GJ, Turnbull TL, Engebretsen L, LaPrade RF. Anatomic Anterolateral Ligament Reconstruction of the Knee Leads to Overconstraint at Any Fixation Angle. Am J Sports Med. 2016 Oct;44(10):2546-2556. doi: 10.1177/0363546516652607. Epub 2016 Jul 12.

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• Sonnery-Cottet B, Barbosa NC, Vieira TD, Saithna A. Clinical outcomes of extra-articular tenodesis/anterolateral reconstruction in the ACL injured knee. Knee Surg Sports Traumatol Arthrosc. 2018 Feb;26(2):596-604. doi: 10.1007/s00167-017-4596-5. Epub 2017 Jun 12.

  PMID: 28608009 BACKGROUND

• Stergiou N, Ristanis S, Moraiti C, Georgoulis AD. Tibial rotation in anterior cruciate ligament (ACL)-deficient and ACL-reconstructed knees: a theoretical proposition for the development of osteoarthritis. Sports Med. 2007;37(7):601-13. doi: 10.2165/00007256-200737070-00004.

  PMID: 17595155 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Fernando C Rezende, MD

  research assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando C Rezende, MD

CONTACT

(55)1155764848; fernandocuryrezende@gmail.com

Carlos Eduardo Franciozi, PhD

CONTACT

(55)1155764848; cacarlos66@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 25, 2017
• Study Start: October 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2022
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

BR (1)