“Malunited distal radius fractures”, “corrective osteotomy”, “bone grafting”, “complications”, “quality of life”, “costs effectiveness”
Conditions
Interventions
Open wedge corrective osteotomy and plate fixation with or without harvesting und using bone from iliac crest.
Sponsors
Maastricht University Medical Center (MUMC+)
P. Debyelaan 25
6229 HX Maastricht
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of either sex over the age of 18 years • Symptomatic malunion of the distal radius • Eligible for open wedge osteotomy and plate fixation with or without bone grafting from iliac crest. • Patients are able to undergo postoperative follow-up of at least 12 months.
Exclusion criteria
Exclusion criteria: Patients with known systemic or metabolic disorders leading to progressive bone deterioration and chronic use of glucocorticoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcomes are: •Complications (number and severity) during and after the operation with a follow-up period of at least one year •Quality of life using the EQ-5D-5L questionnaire •Time to complete bone healing, defined as the time between the corrective osteotomy and bridging of the fracture site by bone or callus | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study outcomes are: • Subjective functional outcomes: Patient-Rated Wrist Evaluation (PRWE) and Disability of the Arm, Shoulder and Hand (DASH) questionnaire • Objective functional outcomes: active range of motion and grip strength • Cost effectiveness (including costs per QALY) | — |
Contacts
Public ContactD. Disseldorp
Medisch Universitair Ziekenhuis Maastricht Afdeling Algemene Heelkunde Postbus 5800
Outcome results
None listed