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PROMOTION-trial: onderzoek naar 2 verschillende chirurgische methoden om een verplaatste breuk van de bovenarm te behandelen.

PROMOTION-trial: A PROspective randomized Multicenter trial for the treatment of dislocated 3-part proximal humerus fractures: Open reduction and internal fixaTION versus intramedullary nailing.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24602
Enrollment
92
Registered
2013-06-03
Start date
2013-08-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bovenarmbreuk humerus fracture

Interventions

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

Sponsors

Maastricht University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Primary endpoint is functional outcome 1 year after surgery indicated by the Constant-Murley scale.

Secondary

MeasureTime frame
Secundary outcomes are DASH-score, pain, SF-12, EQ-5D, complication and mortality rate.

Contacts

Public ContactJeroen Bransen

MUMC, Department of Surgery PO Box 5800

jeroenbransen@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)