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

March 14, 2014 updated by: Arnaldo José Hernandez, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403010
        • Recruiting
        • Instituto de Ortopedia e Traumatologia do HCFMUSP
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Stability with force platform
Time Frame: 12 months
Evaluation of dynamic stability in stand position and leg movements with force platform
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline and between groups in Lysholm knee scoring scale
Time Frame: 6, 12, 24 months
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.
6, 12, 24 months
Change from baseline and between groups in Tegner activity score
Time Frame: 6, 12, 24 months
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.
6, 12, 24 months
Single leg hop test for distance - side to side difference
Time Frame: 6, 12 months
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.
6, 12 months
Isokinetic knee strength test - side to side difference
Time Frame: 6, 12 months
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.
6, 12 months
Change from baseline and between groups in Dynamic Stability with force platform
Time Frame: 6 months
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.
6 months
Change from baseline and between groups in International Knee Documentation Committee form (IKDC)
Time Frame: 6, 12 e 24 months
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
6, 12 e 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Arnaldo J Hernandez, PhD, MSc, MD, University of Sao Paulo
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCFMUSP972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complete Tear, Knee, Anterior Cruciate Ligament

Clinical Trials on Anatomical ACL reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe