Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093763
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-10-10
Brief Title:
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOPPeR
Brief 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 radiographsCT 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
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 radiographsCT 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None