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

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ClinicalTrials.gov Identifier: NCT02290197
Recruitment Status : Unknown
Verified November 2014 by Fábio Janson Angelini, University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Fábio Janson Angelini, University of Sao Paulo General Hospital

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 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.


Condition or disease Intervention/treatment Phase
Knee Dislocation Procedure: Surgery Device: Hinged External Fixator Device: Cast Immobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction. Randomized Prospective Study.
Study Start Date : August 2010
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.


  2. Pain [ Time Frame: 12 months postoperative ]
    Visual Analogue Scale - VAS

  3. IKDC [ Time Frame: 12 months postoperative ]
    Clinical score

  4. Lysholm [ Time Frame: 12 months postoperative ]
    Clinical score

  5. Adverse events [ Time Frame: 12 months postoperative ]
    Adverse events from surgery or rehabilitation period



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290197


Locations
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Brazil
Hospital das Clinicas - University of Sao Paulo
Sao Paulo, Brazil, 05403010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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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 Chair: Gilberto L Camanho, Ph.D. University of Sao Paulo
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Responsible Party: Fábio Janson Angelini, Assistant Physician, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02290197    
Other Study ID Numbers: 0886-09
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Joint Dislocations
Knee Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries