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

N/AUnknownNCT02074917

University of Sao Paulo40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dynamic Stability with force platform

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

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 6, 12, 24 months

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.

Time frame: 6, 12, 24 months

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.

Time frame: 6, 12 months

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.

Time frame: 6, 12 months

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.

Time frame: 6 months

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

Time frame: 6, 12 e 24 months