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…
ID
Bron
Verkorte titel
Aandoening
dislocated midshaft clavicular fractures
gedisloceerde mid-schacht clavicula fracturen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
DASH score 6 months after surgery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Plate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN).
Publiek
E.J.M.M. Verleisdonk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2506968
E.J.M.M.Verleisdonk@umcutrecht.nl
Wetenschappelijk
E.J.M.M. Verleisdonk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2506968
E.J.M.M.Verleisdonk@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Unilateral dislocated midshaft clavicular fracture;
2. No medical contraindications to general anesthesia;
3. Provided informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2332 |
| NTR-old | NTR2438 |
| Ander register | VCMO/METC : R-10.18D |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |