Knee Dislocation Clinical Trial
Official title:
Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction. Randomized Prospective Study.
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 ligament reconstruction
procedures. Simultaneously the investigators allow immediate joint mobilization, reducing
the risk of arthrofibrosis, joint stiffness and postoperative ligament laxity.
There is no consensus regarding the use of hinged external fixator postoperatively in
multiple ligament reconstruction procedures for treatment of knee dislocations.
The objective of this study is comparing functional outcomes after ligament reconstruction
in patients with knee dislocation, with or without the use of hinged external fixator.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00582517 -
Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial
|
N/A |