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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1996 |
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Date of registration:
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08/09/2009 |
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Primary sponsor: |
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Public title:
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A hinged external fixator for complex elbow dislocations: A prospective cohort study.
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Scientific title:
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A hinged external fixator for complex elbow dislocations: A prospective cohort study. - Elbow Fixator |
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Date of first enrolment:
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28/8/2009 |
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Target sample size:
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30 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1996 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: Single; Control: Not applicable; Group: [default]; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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N.W.L.
Schep |
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Address:
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Erasmus MC, dept. of Surgery-Traumatology
Mailbox H-822k
P.O. Box 2040, Erasmus MC, dept. of Surgery-Traumatology
Mailbox H-822k
P.O. Box 2040
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31-10 7031050 |
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Email:
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n.schep@erasmusmc.nl |
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Affiliation:
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Name:
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N.W.L.
Schep |
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Address:
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Erasmus MC, dept. of Surgery-Traumatology
Mailbox H-822k
P.O. Box 2040, Erasmus MC, dept. of Surgery-Traumatology
Mailbox H-822k
P.O. Box 2040
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31-10 7031050 |
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Email:
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n.schep@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Men or women aged 18 years and older (with no upper age limit);
2. Patient with a complex elbow dislocation (i.e., dislocation of the elbow joint, combined with at least a fracture of the radial head, coronoid process, or olecranon);
3. Patient was treated with a hinged external fixator after ORIF and/or arthroplasty due to persistent instability;
4. Provision of informed consent by patient.
Exclusion criteria: 1. Patients with distal intra-articular humeral fractures;
2. Patients with additional traumatic injuries of the affected upper limb;
3. Patients who underwent repair of the collateral ligaments and immobilization;
4. Patients with an impaired elbow function (i.e., stiff or painful elbow or neurological disorder of the upper limb) prior to the injury;
5. Retained hardware around the affected elbow;
6. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded);
7. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information in the judgment of the attending physician;
Exclusion of a patient because of enrolment in another ongoing drug or surgical intervention trial will be left to the discretion of the attending surgeon, on a case-by-case basis.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Complex elbow dislocation
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Intervention(s)
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Hinged external fixator.
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Primary Outcome(s)
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Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) score.
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Secondary Outcome(s)
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1. Mayo Elbow Performance Index (MEPI);
2. Oxford Elbow Score;
3. Pain level (VAS);
4. Range of Motion of the elbow joint;
5. Radiographic healing;
6. Rate of secondary interventions;
7. Rate of complications;
8. Health-related quality of life (SF-36).
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Secondary ID(s)
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NL28503.078.09
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Source(s) of Monetary Support
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Erasmus Medical Center
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