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Gips vergeleken met opereren voor een gebroken pols, wat geeft een beter resultaat bij ouderen?

The effectiveness of surgery versus casting for elderly patients with Displaced distal intra-Articular Radius fractures. A randomized controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24458
Enrollment
154
Registered
2017-01-25
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Distal radius fracture elderly

Interventions

Surgery: open reduction internal fixation by volar (and possibly dorsal plating). Conservative: cast treatment

Sponsors

Dirk ter Meulen, d.p.termeulen@olvg.nl, OLVG oost
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • >65 years at time of trauma • Intra-articular distal radius fracture (AO type C*) • One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation): &#8804;15° inclination 15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm • < 3 weeks post trauma • Living independent at home (e.g. not in a retirement home) • Fit for surgery • Mentally competent The patient must be able to fully understand the consequences of participation. This includes that the patient must be aware of the burden that the research project provides, the possible complications in both treatment arms and the possibility to not participate in the trial. Furthermore he or she must be able to fill out the questionnaires. • Dutch fluency and literacy • Informed consent

Exclusion criteria

Exclusion criteria: • Open fractures • Neurovascular damage • Multiple-trauma patients (ISS >16) • Other fractures in the injured extremity other than ulnar styloid process fractures • Contralateral fracture of the forearm

Design outcomes

Primary

MeasureTime frame
•Wrist function as reported by the patient (Patient-Rated Wrist Evaluation score) (PRWE)) 1 year after trauma

Secondary

MeasureTime frame
• Wrist function as reported by the patient (Disabilities of the Arm, Shoulder and Hand (DASH)) • Quality of life as reported by the patient (EQ-5D) • Patient reported pain catastrophizing (Pain Catastrophizing Scale (PCS)) • Costs evaluation questionnaire • ROM (range of motion)

Contacts

Public ContactDirk ter Meulen

OLVG oost

d.p.termeulen@olvg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)