|- candidate number||8198|
|- NTR Number||NTR2399|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-jul-2010|
|- Secondary IDs||P10-033 / P10.169 LUMC / LUMC|
|- Public Title||Non-operative treatment versus plate fixation in displaced midshaft clavicular fractures.|
|- Scientific Title||Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation. A multi-centre randomised controlled trial in the Netherlands.|
|- Healt Condition(s) or Problem(s) studied||Fracture , Clavicula, Nonoperative treatment, Locking plate fixation|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-mei-2010|
|- planned closingdate||1-sep-2012|
|- Target number of participants||350|
|- Interventions||1. Non-operative treatment with a sling;|
2. Operative treament: Plate fixation.
|- Primary outcome||Complete radiological consolidation.|
|- Secondary outcome||1. Complete functional recovery of the shoulder to the level of mobility prior to fracture;|
3. Quality of life;
4. Cosmetic appearance.
|- Timepoints||0 days, 2 weeks, 6 weeks, 3 months, 1 year.|
|- Trial web site||www.sleutelstudie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S.A. Stegeman|
|- CONTACT for SCIENTIFIC QUERIES|| S.A. Stegeman|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
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.
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.
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.
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)|
|- RECORD||1-jul-2010 - 10-apr-2011|