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| Name | Class |
|---|---|
| Haga Hospital | OTHER |
| Amsterdam UMC | OTHER |
| VieCuri Medical Centre | OTHER |
| Zuyderland Medical Centre |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with symptomatic malunion of distal radius receiving bone grafting | Active Comparator | Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. |
|
| Patients with symptomatic malunion of distal radius receiving none bone grafts | Active Comparator | Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group without bone grafting | Procedure | Open wedge corrective osteotomy and plate fixation without bone grafting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications | number and severity during and after the operation | follow-up period of at least one year |
| Quality of life using the EQ-5D-5L questionnaire | EQ-5D-5L questionnaire | 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. | follow-up period of one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | follow-up period of one year |
| Subjective functional outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Disseldorp, MD | Contact | 0031433877489 | dominique.disseldorp@mumc.nl | |
| Fabienne Hameleers | Contact | 0031433877489 | f.hameleers@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Hannemann, MD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaastrichtUMC | Recruiting | Maastricht | Zuid-Limburg | 6229 HX | Netherlands |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
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| OTHER |
| Elkerliek Hospital | OTHER |
| Erasmus Medical Center | OTHER |
| Amphia Hospital | OTHER |
| Reinier Haga Orthopedisch Centrum | OTHER |
| Flevoziekenhuis | OTHER |
| Diakonessenhuis, Utrecht | OTHER |
| Xpert Clinics | UNKNOWN |
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.
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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
| Group with bone grafting | Procedure | Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. |
|
Patient-Rated Wrist Evaluation (PRWE) Questionnaire: measure of self-rated wrist pain and disability in activities of daily living
| follow-up period of one year |
| Objective functional outcomes | Active range of motion | follow-up period of one year |
| Cost effectiveness | cost-effectiveness analysis | follow-up period of at least one year |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |