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Non-operative treatment versus plate fixation in displaced midshaft clavicular fractures.


- candidate number8198
- NTR NumberNTR2399
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jul-2010
- Secondary IDsP10-033 / P10.169 LUMC / LUMC
- Public TitleNon-operative treatment versus plate fixation in displaced midshaft clavicular fractures.
- Scientific TitleDisplaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation. A multi-centre randomised controlled trial in the Netherlands.
- ACRONYMSleutel-TRIAL
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedFracture , Clavicula, Nonoperative treatment, Locking plate fixation
- Inclusion criteria1. Age 18-60 years;
2. A completely displaced midshaft fracture (no fracture side contact of distal and proximal fragments) according to Robinson classification 2B1 and 2B2;
3. No medical contra indications to general anaesthesia;
4. Signed informed consent by the patient or a legal representative.
- Exclusion criteria1. Patient younger than 18 years or older than 60 years;
2. A fracture in the proximal or distal third of the clavicle;
3. A pathologic fracture (bony abnormalities at the side of the fracture);
4. An open fracture;
5. Neurovascular injury with objective neurological findings on physical examination;
6. An associated head injury (Glasgow Coma Scale <12);
7. An upper extremity fracture distal to the shoulder;
8. A fracture seen more than 14 days after injury;;
9. Inability to give informed consent with the randomisation procedure;
10. A medical contra-indication to surgery/ anaesthesia (such as a heart disease, kidney failure or active chemotherapy);
11. Inability to comply with follow-up;
12. Prior surgery to the shoulder;
13. Prior shoulder complaints.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-mei-2010
- planned closingdate1-sep-2012
- Target number of participants350
- Interventions1. Non-operative treatment with a sling;
2. Operative treament: Plate fixation.
- Primary outcomeComplete radiological consolidation.
- Secondary outcome1. Complete functional recovery of the shoulder to the level of mobility prior to fracture;
2. Complications;
3. Quality of life;
4. Cosmetic appearance.
- Timepoints0 days, 2 weeks, 6 weeks, 3 months, 1 year.
- Trial web sitewww.sleutelstudie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.A. Stegeman
- CONTACT for SCIENTIFIC QUERIES S.A. Stegeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryBackground:
The traditional view that the vast majority of clavicular fractures heal with good functional outcomes following non-operative treatment is no longer valid. Recent studies have identified a higher rate of non-union and specific deficits of shoulder function in subgroups of patients with these injuries.

Objective:
To compare the functional outcome of operative treatment using plate fixation with non-operative treatment for clavicular fractures.

Study design and population:
A multi-centre randomised clinical trial. All persons with a dislocated midshaft clavicular fracture, aged between 18 and 60 years, and eligible to participate, are allowed to join the study group.

Intervention:
350 patients will be included in two groups: One group will have non-operative treatment, the other group will have operative fracture fixation with plates.

Main parameters/endpoints:
Clinical function, radiographic consolidation, functional outcome, painscores, and quality of life will be monitored for each patient during the first year after trauma.
- Main changes (audit trail)
- RECORD1-jul-2010 - 10-apr-2011


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