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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Dislocation
• Intervention / Treatment: Procedure: Surgery; Device: Hinged External Fixator; Device: Cast Immobilization

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403010
    • Hospital das Clínicas - University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hinged External Fixator; 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.	Procedure: Surgery; Surgical reconstruction of all injured ligaments.; Device: Hinged External Fixator; Hinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged.
Active Comparator: Cast Immobilization; In these patients we used cast postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.	Procedure: Surgery; Surgical reconstruction of all injured ligaments.; Device: Cast Immobilization; Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee stability	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)	12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Physical examination performed by an independent investigator (Physical Therapist). Knee range of motion (flexion / extension) in degrees.	12 months postoperative
Pain	Visual Analogue Scale - VAS	12 months postoperative
IKDC	Clinical score	12 months postoperative
Lysholm	Clinical score	12 months postoperative
Adverse events	Adverse events from surgery or rehabilitation period	12 months postoperative

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Gilberto L Camanho, Ph.D., University of Sao Paulo; Principal Investigator: Fabio J Angelini, M.D., University of Sao Paulo; Study Director: Roberto F Mota e Albuquerque, Ph.D., University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: November 8, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 8, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Knee Dislocation
• Other Study ID Numbers: 0886-09