Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction
NCT ID: NCT02290197
Last Updated: 2014-11-13
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2010-08-31
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Cast Immobilization
Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* inability to follow the treatment plan
18 Years
50 Years
ALL
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Fábio Janson Angelini
Assistant Physician
Principal Investigators
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Fabio J Angelini, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Roberto F Mota e Albuquerque, Ph.D.
Role: STUDY_DIRECTOR
University of Sao Paulo
Gilberto L Camanho, Ph.D.
Role: STUDY_CHAIR
University of Sao Paulo
Locations
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Hospital das Clinicas - University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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0886-09
Identifier Type: -
Identifier Source: org_study_id