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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Anatomical ACL reconstruction

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring 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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Instituto de Ortopedia e Traumatologia do HCFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AM anatomical ACL reconstruction

CENTRAL anatomical ACL reconstruction

Arm Description

Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction

Femoral and tibial tunnels performed in the center of ACL footprint

Outcomes

Primary Outcome Measures

Dynamic Stability with force platform

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

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

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

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

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

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)

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

Full Information

NCT ID

NCT02074917

First Posted

October 24, 2013

Last Updated

March 14, 2014

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02074917

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AM anatomical ACL reconstruction

Arm Type

Experimental

Arm Description

Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction

Arm Title

CENTRAL anatomical ACL reconstruction

Arm Type

Experimental

Arm Description

Femoral and tibial tunnels performed in the center of ACL footprint

Intervention Type

Procedure

Intervention Name(s)

Anatomical ACL reconstruction

Other Intervention Name(s)

anatomic ACL reconstruction, anatomic anterior cruciate ligament reconstruction, anatomical anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction, anterior cruciate ligament, ACL

Intervention Description

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

Primary Outcome Measure Information:

Title

Dynamic Stability with force platform

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change from baseline and between groups in Lysholm knee scoring scale

Description

Time Frame

6, 12, 24 months

Title

Change from baseline and between groups in Tegner activity score

Description

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.

Time Frame

6, 12, 24 months

Title

Single leg hop test for distance - side to side difference

Description

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.

Time Frame

6, 12 months

Title

Isokinetic knee strength test - side to side difference

Description

Time Frame

6, 12 months

Title

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

Description

Time Frame

6 months

Title

Change from baseline and between groups in International Knee Documentation Committee form (IKDC)

Description

Time Frame

6, 12 e 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnaldo J Hernandez, PhD, MSc, MD

Phone

+551126616041

ajhernandez@uol.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Danilo RO Oliveira, Phisycian

Phone

+5511983697729

ortopedistadanilo@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaldo J Hernandez, PhD, MSc, MD

Organizational Affiliation

University of São Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Danilo RO Oliveira, MD

Organizational Affiliation

University of São Paulo

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tiago L Fernandes, MSc, MD

Organizational Affiliation

University of São Paulo

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ellen CR Felix

Organizational Affiliation

University of São Paulo

Official's Role

Study Director

Facility Information:

Facility Name

Instituto de Ortopedia e Traumatologia do HCFMUSP

City

São Paulo

State/Province

ZIP/Postal Code

05403010

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danilo RO Oliveira, MD

Phone

+5511983697729

ortopedistadanilo@hotmail.com

First Name & Middle Initial & Last Name & Degree

Tiago L Fernandes, MSc, MD

Phone

+5511983830123

tiago.lazzaretti@usp.br

First Name & Middle Initial & Last Name & Degree

Arnaldo J Hernandez, PhD, MSc, MD

First Name & Middle Initial & Last Name & Degree

Tiago L Fernandes, MSc, MD

First Name & Middle Initial & Last Name & Degree

Danilo RO Oliveira, MD

First Name & Middle Initial & Last Name & Degree

Ellen CR Felix

12. IPD Sharing Statement

Citations:

PubMed Identifier

17932407

Citation

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.

Results Reference

background

PubMed Identifier

21316972

Citation

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.

Results Reference

background

PubMed Identifier

20516317

Citation

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.

Results Reference

background

PubMed Identifier

15722268

Citation

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.

Results Reference

background

PubMed Identifier

22124847

Citation

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.

Results Reference

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

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