No registrations found.
Source
Brief title
Health condition
dislocated midshaft clavicular fractures
gedisloceerde mid-schacht clavicula fracturen
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
DASH score 6 months after surgery.
Secondary outcome
1. 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.
Background summary
Prospective 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.
Study objective
The 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.
Study design
6 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.
Intervention
Plate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN).
E.J.M.M. Verleisdonk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2506968
E.J.M.M.Verleisdonk@umcutrecht.nl
E.J.M.M. Verleisdonk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2506968
E.J.M.M.Verleisdonk@umcutrecht.nl
Inclusion criteria
1. Unilateral dislocated midshaft clavicular fracture;
2. No medical contraindications to general anesthesia;
3. Provided informed consent.
Exclusion criteria
1. 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2332 |
NTR-old | NTR2438 |
Other | VCMO/METC : R-10.18D |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |