Clinical Trial: Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction. Randomized Prospective Study.

Brief Summary:

Knee dislocation is a serious injury, usually caused by high-energy trauma. It is classically defined as complete loss of articular congruence between the femur and the tibia, confirmed by radiography. However it is common that the reduction happens spontaneously. For this reason, today the investigators also consider a patient suffered knee dislocation in the presence of multi-ligament injury involving the posterior cruciate ligament, often in association with anterior cruciate ligament, lateral and/or medial ligamentous complex.

It is considered a serious injury, because both the strong association with vascular and nerve damage, which can lead to the need for limb amputation, such as the difficulty in obtaining a good functional outcome even after treatment of all ligament injuries.

The treatment of these injuries aims to achieve knee stability. Joint mobility is often sacrificed in the postoperative period, with the use of immobilizations such as casts, splints or bracing. Unfavorable clinical outcomes with high rates of stiffness and joint pain are very common in these patients. In attempts to improve these results, rehabilitation protocols with early range of motion can be employed. However, results may remain unsatisfactory, predominantly because of knee instability recurrence.

Stannard and Zaffagnini proposed a new model for treatment of acute knee dislocations. In this model, after multi-ligament reconstruction or repair, a knee articulated external fixator is used. Such external fixator allows early and aggressive joint mobility in the sagittal plane only. Flexion and extension are permitted, but rotational movements, translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings are not allowed. Thus protective stability is ensured for

Detailed Summary:
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Knee stability [ Time Frame: 12 months postoperative ]

Physical examination performed by an independent investigator (Physical Therapist).

Evaluation of posterior drawer according to the IKDC objective criteria: A (normal - 0 to 2mm); B (near normal - 3 to 5 mm); C (abnormal - 6 to 10mm); D (severely abnormal - greater than 10mm).

Evaluation of the posterior lateral corner according to the IKDC objective - External Rotation Test (patient in prone position, knee flexed 90 degrees). A (normal - < 5 degrees); B (near normal - 6 to 10 degrees); C (abnormal - 11 to 19 degrees); D (severely abnormal - greater than 20 degrees)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Range of motion [ Time Frame: 12 months postoperative ]

    Physical examination performed by an independent investigator (Physical Therapist).

    Knee range of motion (flexion / extension) in degrees.

  • Pain [ Time Frame: 12 months postoperative ]
    Visual Analogue Scale - VAS
  • IKDC [ Time Frame: 12 months postoperative ]
    Clinical score
  • Lysholm [ Time Frame: 12 months postoperative ]
    Clinical score
  • Adverse events [ Time Frame: 12 months postoperative ]
    Adverse events from surgery or rehabilitation period


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: October 29, 2014
Date Started: August 2010
Date Completion: March 2015
Last Updated: November 8, 2014
Last Verified: November 2014