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Surgical treatment of midshaft clavicular fractures with dislocation: Plate fixation versus intramedullary fixation.


- candidate number8279
- NTR NumberNTR2438
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-aug-2010
- Secondary IDsR-10.18D VCMO/METC
- Public TitleSurgical treatment of midshaft clavicular fractures with dislocation: Plate fixation versus intramedullary fixation.
- Scientific TitleSurgical treatment of midshaft clavicular fractures with dislocation: Plate fixation versus intramedullary fixation.
- ACRONYMThe Plate Or Pin study: “POP” study
- hypothesisThe null hypothesis of the primary outcome measure is that there will be no significant differences in DASH scores 6 months after surgery between patients who underwent plate fixation or intramedullary fixation with a TEN. The alternate hypothesis is that DASH scores 6 months after surgery demonstrate a significant difference.
- Healt Condition(s) or Problem(s) studiedDislocated midshaft clavicular fractures
- Inclusion criteria1. Unilateral dislocated midshaft clavicular fracture;
2. No medical contraindications to general anesthesia;
3. Provided informed consent.
- Exclusion criteria1. Age < 18 years or > 65 years;
2. Multitrauma patients;
3. Open fracture;
4. Pathological fracture;
5. Fracture > 1 month old;
6. Neurovascular disorders;
7. Glasgow Coma Scale <12 (moderate to severe head injury);
8. An inability to comply with follow-up (a transient or an inability to read or complete forms);
9. Pre-existing shoulder pathology in affected side (such as rotator cuff lesion, acromioclavicular pathology or previous shoulder surgery).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jul-2012
- Target number of participants120
- InterventionsPlate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN).
- Primary outcomeDASH score 6 months after surgery.
- Secondary outcome1. Function of the shoulder (Constant Score) 6 months after surgery;
2. DASH and Constant scores at 6 weeks and 3 months;
3. Complications, both intra-operatively, immediately postoperatively (two weeks), and after 6 months;
3. The number of re-operations related to unsatisfactory results in a period of 6 months;
4. Time to radiological consolidation;
5. Perception of pain 2 weeks postoperatively;
6. Patient satisfaction with the cosmetic result of the treatment 6 months postoperatively.
- Timepoints6 months after surgery: DASH, Constant, complications, number of re-operations, cosmetic result.
3 months after surgery: DASH, Constant.
6 weeks after surgery: DASH, Constant.
2 weeks after surgery: complications, perception of pain.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. E.J.M.M. Verleisdonk
- CONTACT for SCIENTIFIC QUERIESDr. E.J.M.M. Verleisdonk
- Sponsor/Initiator Diakonessenhuis Utrecht, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Diakonessenhuis Utrecht, Department of Surgery
- PublicationsN/A
- Brief summaryProspective randomised study comparing results of plate fixation and intramedullary fixation for dislocated midshaft clavicular fractures postoperatively after two weeks and after a follow-up period of six months.
- Main changes (audit trail)
- RECORD1-aug-2010 - 22-sep-2013


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