Overview

This trial is active, not recruiting.

Condition knee dislocation
Treatments surgery, hinged external fixator, cast immobilization
Sponsor University of Sao Paulo General Hospital
Start date August 2010
End date November 2014
Trial size 40 participants
Trial identifier NCT02290197, 0886-09

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hinged 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 we allow immediate joint mobilization, reducing the risk of arthrofibrosis, joint stiffness and postoperative ligament laxity.
surgery
Surgical reconstruction of all injured ligaments.
hinged external fixator
Hinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged.
(Active Comparator)
In these patients we used cast postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.
surgery
Surgical reconstruction of all injured ligaments.
cast immobilization
Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.

Primary Outcomes

Measure
Knee stability
time frame: 12 months postoperative

Secondary Outcomes

Measure
Range of motion
time frame: 12 months postoperative
Pain
time frame: 12 months postoperative
IKDC
time frame: 12 months postoperative
Lysholm
time frame: 12 months postoperative
Adverse events
time frame: 12 months postoperative

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - adults aged between 18 and 50 years old, diagnosed with knee dislocation, classified as KD-III and KD-IV - absence of knee arthritis in initial radiographs - absence of systemic diseases or disorders of collagen altering bone quality - absence of previous surgical interventions in the knee - possibility of using medications - maximum of three months of injury to treatment - understanding and acceptance by the patient to participate Exclusion Criteria: - abandoning medical care - inability to follow the treatment plan

Additional Information

Official title Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction. Randomized Prospective Study.
Principal investigator Fabio J Angelini, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.