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

NCT02290197 | Unknown

• 1 other identifier: 0886-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Dislocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Range of motion

  12 months postoperative

• Pain

  12 months postoperative

• IKDC

  12 months postoperative

• Lysholm

  12 months postoperative

• Adverse events

  12 months postoperative

Study Arms (2)

Hinged External Fixator

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.

Procedure: Surgery; Device: Hinged External Fixator

Cast Immobilization

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.

Procedure: Surgery; Device: Cast Immobilization

Interventions

Surgery PROCEDURE

Surgical reconstruction of all injured ligaments.

Cast Immobilization; Hinged External Fixator

Hinged External Fixator DEVICE

Hinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged.

Hinged External Fixator

Cast Immobilization DEVICE

Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.

Cast Immobilization

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• abandoning medical care
• inability to follow the treatment plan

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas - University of Sao Paulo

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Knee Dislocation

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Officials

• Fabio J Angelini, M.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Roberto F Mota e Albuquerque, Ph.D.

  University of Sao Paulo

  STUDY DIRECTOR

• Gilberto L Camanho, Ph.D.

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 13, 2014
• Study Start: August 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

BR (1)