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

Not Applicable

• Conditions: Rupture of Anterior Cruciate Ligament; Complete Tear, Knee, Anterior Cruciate Ligament
• Interventions: Procedure: Anatomical ACL reconstruction

• Registration Number: NCT02074917
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-18
• Primary Completion: 2014-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AM anatomical ACL reconstruction	Anatomical ACL reconstruction	Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction
CENTRAL anatomical ACL reconstruction	Anatomical ACL reconstruction	Femoral and tibial tunnels performed in the center of ACL footprint

Primary Outcome Measures

Name	Time	Method
Dynamic Stability with force platform	12 months	Evaluation of dynamic stability in stand position and leg movements with force platform

Secondary Outcome Measures

Name	Time	Method
Isokinetic knee strength test - side to side difference	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.
Change from baseline and between groups in Dynamic Stability with force platform	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.
Change from baseline and between groups in International Knee Documentation Committee form (IKDC)	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
Change from baseline and between groups in Lysholm knee scoring scale	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.
Change from baseline and between groups in Tegner activity score	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.
Single leg hop test for distance - side to side difference	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.

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia do HCFMUSP; 🇧🇷 São Paulo, SP, Brazil