Malunion of Fracture of Radius
Conditions
Keywords
open wedge osteotomy, bone grafting, time of bone healing, complications, Quality of life, Subjective and objective functional outcomes, Cost effectiveness
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) 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.
Interventions
PROCEDUREGroup without bone grafting
Open wedge corrective osteotomy and plate fixation without bone grafting.
PROCEDUREGroup with bone grafting
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Sponsors
Haga Hospital
Amsterdam UMC
VieCuri Medical Centre
Zuyderland Medical Centre
Elkerliek Hospital
Erasmus Medical Center
Amphia Hospital
Reinier Haga Orthopedisch Centrum
Flevoziekenhuis
Diakonessenhuis, Utrecht
Xpert Clinics
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A web based randomisation tool will used for randomization according to the GCP-guidelines. Prestratification per hospital will be performed. Patients and the treating surgeon cannot be blinded for the treatment because a part of these patients will undergo bone grafting derived from the iliac crest. The statistician will be blinded for the treatment. 6.3 Study
Intervention model description
All included patients will undergo an open wedge osteotomy and plate fixation according to the standard surgical techniques. In one group, the bone defect will be filled with bone graft of the iliac crest after open wedge osteotomy according the standard procedure. The other group includes patients who will not receive any bone grafts. The participating hospitals have extensive experience with both treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Patients who are pregnant * Patients who have known systemic or metabolic disorders leading to progressive bone deterioration * Patients who take chronic use of glucocorticoids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | follow-up period of at least one year | number and severity during and after the operation |
| Quality of life using the EQ-5D-5L questionnaire | follow-up period of one year | EQ-5D-5L questionnaire |
| Time to complete bone healing | follow-up period of one year | Bone healing will be considered complete when the osteotomy gap is filled with bone formation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective functional outcomes | follow-up period of one year | Disability of the Arm, Shoulder and Hand Questionnaire (DASH): measure of self-rated upper-extremity disability and symptoms in activities of daily living |
| Cost effectiveness | follow-up period of at least one year | cost-effectiveness analysis |
| Subjective functional outcome | follow-up period of one year | Patient-Rated Wrist Evaluation (PRWE) Questionnaire: measure of self-rated wrist pain and disability in activities of daily living |
| Objective functional outcomes | follow-up period of one year | Active range of motion |
Countries
Netherlands
Contacts
Primary ContactDominique Disseldorp, MD
Backup ContactFabienne Hameleers
Outcome results
None listed