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VIPER, operatie versus gips bij polsfracturen.

Volar plate fixation versus plaster in displaced extra-articular distal radius fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26639
Enrollment
90
Registered
2011-10-22
Start date
2012-09-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Distal radius fractures

Interventions

This study will randomise between open reduction and internal fixation with a volar locking plate and plaster immobilisation.

Sponsors

Academic Medical Centre Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients >18 years <75; 2. AO type A displaced distal radius fracture; 3. Fracture displacement is defined by the AO foundation as fragments not perfectly anatomically aligned; 4. Acceptable closed reduction obtained immediately after presentation at the Emergency Department (<12hrs).

Exclusion criteria

Exclusion criteria: 1. Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb; 2. Open distal radius fractures; 3. Multiple trauma patients; 4. Other fractures in the affected extremity; 5. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician; 6. Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget’s disease, renal osteodystrophy, osteomalacia); 7. Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan’s, Ehler Danlos or other related disorders.

Design outcomes

Primary

MeasureTime frame
Disability of the Arm, Shoulder and Hand (DASH) questionnaire

Secondary

MeasureTime frame
Patient-Rated Wrist Evaluation (PRWE) score, quality of life (SF-36), pain as indicated on a Visual Analogue Scale (VAS), range of motion (ROM), grip strength, radiological outcome and complications.

Contacts

Public ContactMarjolein A.M. Mulders
m.a.mulders@amc.nl020-5660260

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)