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

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.

Conditions

• Malunion of Fracture of Radius

Interventions

PROCEDURE

Group without bone grafting

Open wedge corrective osteotomy and plate fixation without bone grafting.

PROCEDURE

Group with bone grafting

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Sponsors & Collaborators

• Haga Hospital

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• VieCuri Medical Centre

  collaborator OTHER

• Zuyderland Medical Centre

  collaborator OTHER

• Elkerliek Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Reinier Haga Orthopedisch Centrum

  collaborator OTHER

• Flevoziekenhuis

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Xpert Clinics

  collaborator UNKNOWN

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Pascal Hannemann, MD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• Netherlands

Study Locations