An interventional study of Group without bone grafting and Group with bone grafting in Malunion of Fracture of Radius, sponsored by Maastricht University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 218 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Procedure: Group with bone grafting
Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.
Procedure: Group without bone grafting
Open wedge corrective osteotomy and plate fixation without bone grafting.
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Complications
number and severity during and after the operation
Time frame: follow-up period of at least one year
Quality of life using the EQ-5D-5L questionnaire
EQ-5D-5L questionnaire
Time frame: follow-up period of one year
Time to complete bone healing
Bone healing will be considered complete when the osteotomy gap is filled with bone formation.
Time frame: follow-up period of one year
Subjective functional outcomes
Disability of the Arm, Shoulder and Hand Questionnaire (DASH): measure of self-rated upper-extremity disability and symptoms in activities of daily living
Time frame: follow-up period of one year
Subjective functional outcome
Patient-Rated Wrist Evaluation (PRWE) Questionnaire: measure of self-rated wrist pain and disability in activities of daily living
Time frame: follow-up period of one year
Objective functional outcomes
Active range of motion
Time frame: follow-up period of one year
Cost effectiveness
cost-effectiveness analysis
Time frame: follow-up period of at least one year
Plan to share: No
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Maastricht University Medical Center