Knee DislocationNCT02290197
Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction
A study testing Surgery, Hinged External Fixator and Cast Immobilization in people with Knee Dislocation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Dislocation
- What is being tested?
- Surgery, Hinged External Fixator and Cast Immobilization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- abandoning medical care
- inability to follow the treatment plan
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - University of Sao Paulo
São Paulo, São Paulo, 05403010
About this study
Official title: 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.
Read more
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
- Being tested
- Surgery, Hinged External Fixator, Cast Immobilization
- Medical subject headings
- Knee Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical reconstruction of all injured ligaments.
Hinged External FixatorDevice
Hinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged.
Cast ImmobilizationDevice
Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgery; Device: Cast Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months postoperative
Secondary outcomes (5)
Range of motion
Physical examination performed by an independent investigator (Physical Therapist).
Knee range of motion (flexion / extension) in degrees.
Measured: 12 months postoperative
Pain
Visual Analogue Scale - VAS
Measured: 12 months postoperative
IKDC
Clinical score
Measured: 12 months postoperative
Lysholm
Clinical score
Measured: 12 months postoperative
Adverse events
Adverse events from surgery or rehabilitation period
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startAug 2010
- Primary completionNov 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DislocationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fábio Janson Angelini, University of Sao Paulo General Hospital
- Investigators
- Fabio J Angelini, M.D., Principal investigator, University of Sao PauloRoberto F Mota e Albuquerque, Ph.D., Study director, University of Sao PauloGilberto L Camanho, Ph.D., Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290197
- Sponsor's protocol ID
- 0886-09
- Status last verified
- Nov 2014
- First submitted
- 29 Oct 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction. Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT02290197
- Acronym / sponsor ID
- 0886-09
- Conditions
- Knee Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hinged External Fixator | Experimental | Procedure: Surgery, Device: Hinged External FixatorHinged 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. |
| Cast Immobilization | Active comparator | Procedure: Surgery, Device: Cast ImmobilizationIn these patients we used cast postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- abandoning medical care
- inability to follow the treatment plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgical reconstruction of all injured ligaments. | Procedure or surgery | Cast Immobilization, Hinged External Fixator |
| Hinged External FixatorHinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged. | Device | Hinged External Fixator |
| Cast ImmobilizationCast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy. | Device | Cast Immobilization |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio J Angelini, M.D. principal investigator
University of Sao Paulo
Roberto F Mota e Albuquerque, Ph.D. study director
University of Sao Paulo
Gilberto L Camanho, Ph.D. study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery, Hinged External Fixator and Cast Immobilization in people with Knee Dislocation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee stability (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.