Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position

NCT02074917 | Unknown

• 1 other identifier: HCFMUSP972
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction. One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately. This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint. It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.

Conditions

Rupture of Anterior Cruciate Ligament; Complete Tear, Knee, Anterior Cruciate Ligament

Keywords

anterior cruciate ligament; ACL; anterior cruciate ligament reconstruction; outcome assessment; outcome assessment, patient; treatment outcome; exercise test; anatomic; anatomical; single-bundle; force platform; postural balance; biomechanics; CT scan; X-ray computed tomography; tomography; diagnostic imaging; knee; knee injuries; joint instability; reconstructive surgical procedures; knee surgery; arthroscopy; athletes; sports medicine; humans; prospective studies; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Dynamic Stability with force platform

  Evaluation of dynamic stability in stand position and leg movements with force platform

  12 months

Secondary Outcomes (6)

• Change from baseline and between groups in Lysholm knee scoring scale

  6, 12, 24 months

• Change from baseline and between groups in Tegner activity score

  6, 12, 24 months

• Single leg hop test for distance - side to side difference

  6, 12 months

• Isokinetic knee strength test - side to side difference

  6, 12 months

• Change from baseline and between groups in Dynamic Stability with force platform

  6 months

Study Arms (2)

AM anatomical ACL reconstruction

EXPERIMENTAL

Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction

Procedure: Anatomical ACL reconstruction

CENTRAL anatomical ACL reconstruction

EXPERIMENTAL

Femoral and tibial tunnels performed in the center of ACL footprint

Procedure: Anatomical ACL reconstruction

Interventions

Anatomical ACL reconstruction PROCEDURE

Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.

Also known as: anatomic ACL reconstruction, anatomic anterior cruciate ligament reconstruction, anatomical anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction, anterior cruciate ligament, ACL

AM anatomical ACL reconstruction; CENTRAL anatomical ACL reconstruction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physical activity classified by Tegner scale ≥ 5
• Absence of other associated ligament injuries in the operated knee
• No ACL rerupture or previous ACL reconstruction in the same or other knee
• Absence of untreated lesions of the opposite knee
• No obvious change in the alignment of the mechanical axis that required surgical correction
• Athletes of both gender with a minimum age of 18 years and maximum of 45 years
• Signature of the consent term (IRB)
• Not be pregnant.

You may not qualify if:

• Request to stop the study by patient at any time
• Fracture not associated with the surgical procedure
• Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia do HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

Related Publications (5)

• Zantop T, Wellmann M, Fu FH, Petersen W. Tunnel positioning of anteromedial and posterolateral bundles in anatomic anterior cruciate ligament reconstruction: anatomic and radiographic findings. Am J Sports Med. 2008 Jan;36(1):65-72. doi: 10.1177/0363546507308361. Epub 2007 Oct 11.

  PMID: 17932407 BACKGROUND

• Misonoo G, Kanamori A, Ida H, Miyakawa S, Ochiai N. Evaluation of tibial rotational stability of single-bundle vs. anatomical double-bundle anterior cruciate ligament reconstruction during a high-demand activity - a quasi-randomized trial. Knee. 2012 Mar;19(2):87-93. doi: 10.1016/j.knee.2011.01.003. Epub 2011 Feb 12.

  PMID: 21316972 BACKGROUND

• Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.

  PMID: 20516317 BACKGROUND

• Musahl V, Plakseychuk A, VanScyoc A, Sasaki T, Debski RE, McMahon PJ, Fu FH. Varying femoral tunnels between the anatomical footprint and isometric positions: effect on kinematics of the anterior cruciate ligament-reconstructed knee. Am J Sports Med. 2005 May;33(5):712-8. doi: 10.1177/0363546504271747. Epub 2005 Feb 16.

  PMID: 15722268 BACKGROUND

• Mohammadi F, Salavati M, Akhbari B, Mazaheri M, Khorrami M, Negahban H. Static and dynamic postural control in competitive athletes after anterior cruciate ligament reconstruction and controls. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1603-10. doi: 10.1007/s00167-011-1806-4. Epub 2011 Nov 29.

  PMID: 22124847 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries; Joint Instability

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Arnaldo J Hernandez, PhD, MSc, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Danilo RO Oliveira, MD

  University of Sao Paulo

  STUDY DIRECTOR

• Tiago L Fernandes, MSc, MD

  University of Sao Paulo

  STUDY DIRECTOR

• Ellen CR Felix

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Arnaldo J Hernandez, PhD, MSc, MD

CONTACT

+551126616041; ajhernandez@uol.com.br

Danilo RO Oliveira, Phisycian

CONTACT

+5511983697729; ortopedistadanilo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, MSc, MD

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: February 28, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

BR (1)