Trial record 3 of 3 for:    Open Studies | "Sports Medicine"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Arnaldo José Hernandez, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02074917
First received: October 24, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Rupture of Anterior Cruciate Ligament
Complete Tear, Knee, Anterior Cruciate Ligament
Procedure: Anatomical ACL reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Dynamic Stability with force platform [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of dynamic stability in stand position and leg movements with force platform


Secondary Outcome Measures:
  • Change from baseline and between groups in Lysholm knee scoring scale [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    This is a validated scoring scale to evaluate outcomes of knee ligament surgery, particularly symptoms of instability. The total score is the sum of each response to the 8 items, of a possible score of 100.

  • Change from baseline and between groups in Tegner activity score [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    This is a validated score for level of activity related to knee stability. It provides a standardized method of grading work and sporting activities from 0 to 10.

  • Single leg hop test for distance - side to side difference [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
    This test includes a single leg hop for distance comparison between involved leg vs. contra-lateral normal leg. Results are expressed as a percentage of the non-involved leg.

  • Isokinetic knee strength test - side to side difference [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
    Quadriceps and hamstring isokinetic strength are assessed at velocities of 60 and 240 degrees per second and values are compared between involved operated leg and non-involved leg and between groups. Peak torque and flexion/extension rate are analyzed.

  • Change from baseline and between groups in Dynamic Stability with force platform [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of dynamic stability in stand position and leg movements with force platform. Antero-posterior and latero-medial movements are measured in metric scale. Area and velocity of movement are also calculated.

  • Change from baseline and between groups in International Knee Documentation Committee form (IKDC) [ Time Frame: 6, 12 e 24 months ] [ Designated as safety issue: No ]
    The form is used to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. It is a validated 18-item patient measurement tool. that can be used for post-operatory ACL reconstruction


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AM anatomical ACL reconstruction
Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction
Procedure: Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
Other Names:
  • anatomic ACL reconstruction
  • anatomic anterior cruciate ligament reconstruction
  • anatomical anterior cruciate ligament reconstruction
  • anterior cruciate ligament reconstruction
  • anterior cruciate ligament
  • ACL
Experimental: CENTRAL anatomical ACL reconstruction
Femoral and tibial tunnels performed in the center of ACL footprint
Procedure: Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
Other Names:
  • anatomic ACL reconstruction
  • anatomic anterior cruciate ligament reconstruction
  • anatomical anterior cruciate ligament reconstruction
  • anterior cruciate ligament reconstruction
  • anterior cruciate ligament
  • ACL

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074917

Contacts
Contact: Arnaldo J Hernandez, PhD, MSc, MD +551126616041 ajhernandez@uol.com.br
Contact: Danilo RO Oliveira, Phisycian +5511983697729 ortopedistadanilo@hotmail.com

Locations
Brazil
Instituto de Ortopedia e Traumatologia do HCFMUSP Recruiting
São Paulo, SP, Brazil, 05403010
Contact: Danilo RO Oliveira, MD    +5511983697729    ortopedistadanilo@hotmail.com   
Contact: Tiago L Fernandes, MSc, MD    +5511983830123    tiago.lazzaretti@usp.br   
Principal Investigator: Arnaldo J Hernandez, PhD, MSc, MD         
Sub-Investigator: Tiago L Fernandes, MSc, MD         
Sub-Investigator: Danilo RO Oliveira, MD         
Sub-Investigator: Ellen CR Felix         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Arnaldo J Hernandez, PhD, MSc, MD University of São Paulo
Study Director: Danilo RO Oliveira, MD University of São Paulo
Study Director: Tiago L Fernandes, MSc, MD University of São Paulo
Study Director: Ellen CR Felix University of São Paulo
  More Information

Publications:
Responsible Party: Arnaldo José Hernandez, Associate Professor, PhD, MSc, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02074917     History of Changes
Other Study ID Numbers: HCFMUSP972
Study First Received: October 24, 2013
Last Updated: March 14, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
sports medicine
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
humans
prospective studies
Randomized Controlled Trial

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014