Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation

Study Overview
=================
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.

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

Conditions
-----------------
Malunion of Fracture of Radius

Intervention / Treatment
-----------------
* Procedure: Group without bone grafting
* Procedure: Group with bone grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with symptomatic malunion of distal radius receiving bone grafting<br>Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. | Procedure: Group with bone grafting<br>* Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.<br>|
| Active Comparator: Patients with symptomatic malunion of distal radius receiving none bone grafts<br>Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest. | Procedure: Group without bone grafting<br>* Open wedge corrective osteotomy and plate fixation without bone grafting.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open wedge osteotomy, bone grafting, time of bone healing, complications, Quality of life, Subjective and objective functional outcomes, Cost effectiveness