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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06093763

Collaborator

Haga Hospital (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), VieCuri Medical Centre (Other), Zuyderland Medical Centre (Other), Elkerliek Hospital (Other), Erasmus Medical Center (Other), Amphia Hospital (Other), Reinier Haga Orthopedisch Centrum (Other), Flevoziekenhuis (Other), Diakonessenhuis, Utrecht (Other), Xpert Clinics (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malunion of Fracture of Radius	Procedure: Group without bone grafting Procedure: Group with bone grafting	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant)

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients with symptomatic malunion of distal radius receiving bone grafting 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 with harvesting and using bone from the iliac crest.
Active Comparator: Patients with symptomatic malunion of distal radius receiving none bone grafts 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.

Arm

Intervention/Treatment

Active Comparator: Patients with symptomatic malunion of distal radius receiving bone grafting

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 with harvesting and using bone from the iliac crest.

Active Comparator: Patients with symptomatic malunion of distal radius receiving none bone grafts

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
Cost effectiveness [follow-up period of at least one year]
cost-effectiveness analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.