No registrations found.
ID
Source
Brief title
Health condition
bovenarmbreuk
humerus fracture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is functional outcome 1 year after surgery indicated by the Constant-Murley scale.
Secondary outcome
Secundary outcomes are DASH-score, pain, SF-12, EQ-5D, complication and mortality rate.
Background summary
With an aging population the incidence of humerusfractures will rise. Dislocated 3-part proximal humerus fractures are treated either by open reduction and internal plate-fixation (Philos, Synthes) or by intramedullary nailing (T2 PHN, Stryker). Until now there have been no randomized controlled trials to proof one of these methods to be superior. The goal of this trial is to point out the surgical intervention with the best functional outcome, measured in Constant-Murley score after 1 year.
Study objective
Intramedullary nailing with the T2 proximal humerus nail results in higher Constant-Murley Score after 1 year compared with open reduction and internal fixation with the Philos plate.
Study design
2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 year after surgery
Intervention
Patients with a 3-part displaced proximal humeral fracture have an indication for surgical treatment. Until now there is no superior technique. Therefore patients will be randomized for osteosynthesis using the Philos plate (Proximal humeral internal locking system, Synthes) or PHN (Proximal Humeral Nailing system, Stryker).
The primary outcome is the Constant-Murley score after 1 year of follow-up. This is the recommended score to express schoulder function. The intervention is the only difference between the 2 groups. Follow-up duration and schedule is similar.
PO Box 5800
Jeroen Bransen
Maastricht 6202 AZ
The Netherlands
jeroenbransen@gmail.com
PO Box 5800
Jeroen Bransen
Maastricht 6202 AZ
The Netherlands
jeroenbransen@gmail.com
Inclusion criteria
1. Adult men and women aged 18 years or older;
2. Unilateral acute dislocated three-part proximal humeral fracture (>45 degrees of angulation or > 0,5 cm of dislocation between major fracture fragments);
3. Fit for surgery;
4. Operative treatment within 21 days post-fracture;
5. Provision of informed consent by patient.
Exclusion criteria
1. bilateral proximal humeral fractures;
2. other major trauma / fractures;
3. pathological, recurrent or open fractures;
4. pre-existing impaired shoulder function (i.e., stiff or painful shoulder, neurologic disorder of the upper limb, or diagnosed rotator cuff impairment;
5. Retained hardware around the affected humerus;
6. a disorder of bone metabolism other than osteoporosis (i.e., Paget’s disease, renal osteodystrophy, osteomalacia);
7. Moderate or severe cognitively impaired patients (i.e., Mini-Mental Status Examination (MMSE) Six Item Screener with 3 or more errors);
8. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded);
9. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgment of the attending physician;
10. Patients with follow-up in other then the participating hospitals.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3859 |
| NTR-old | NTR4019 |
| CCMO | NL40644.068.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON43697 |