Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

INTRODUCTION A variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. The idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. However, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. As these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius OBJECTIVE The objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures. STUDY DESIGN This is a prospective, randomized, controlled multicenter study. Patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/CT scans will be made. STUDY POPULATION All patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction. INTERVENTION Surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting. USUAL CARE Open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest. OUTCOME MEASURES Primary outcomes: complications and quality of life. Secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
MaastrichtUMC
RECRUITING
Maastricht
Contact Information
Primary
Dominique Disseldorp, MD
dominique.disseldorp@mumc.nl
0031433877489
Backup
Fabienne Hameleers
f.hameleers@mumc.nl
0031433877489
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Active_comparator: Patients with symptomatic malunion of distal radius receiving bone grafting
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Active_comparator: Patients with symptomatic malunion of distal radius receiving none bone grafts
Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.
Related Therapeutic Areas
Sponsors
Collaborators: VieCuri Medical Centre, Amphia Hospital, Elkerliek Hospital, Flevoziekenhuis, Reinier Haga Orthopedisch Centrum, Amsterdam UMC, Zuyderland Medical Centre, Haga Hospital, Diakonessenhuis, Utrecht, Erasmus Medical Center, Xpert Clinics
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov