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

U

University of Sao Paulo

Status

Unknown

Conditions

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

Treatments

Procedure: Anatomical ACL reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02074917
HCFMUSP972

Details and patient eligibility

About

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.

Full description

Tunnel position will be recorded and confirmed with postoperative computer tomography.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

AM anatomical ACL reconstruction
Experimental group
Description:
Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction
Treatment:
Procedure: Anatomical ACL reconstruction
CENTRAL anatomical ACL reconstruction
Experimental group
Description:
Femoral and tibial tunnels performed in the center of ACL footprint
Treatment:
Procedure: Anatomical ACL reconstruction

Trial contacts and locations

1

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Central trial contact

Arnaldo J Hernandez, PhD, MSc, MD; Danilo RO Oliveira, Phisycian

Data sourced from clinicaltrials.gov

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