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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malunion of Fracture of Radius
• Intervention / Treatment: Procedure: Group with bone grafting; Procedure: Group without bone grafting

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique Disseldorp, MD; Phone Number: 0031433877489; Email: dominique.disseldorp@mumc.nl
• Study Contact Backup: Name: Fabienne Hameleers; Phone Number: 0031433877489; Email: f.hameleers@mumc.nl

Study Locations

• Netherlands
  • Zuid-Limburg
    • Maastricht, Zuid-Limburg, Netherlands, 6229 HX
      • Recruiting
      • MaastrichtUMC
      • Contact: Dominique Disseldorp, MD; Phone Number: 0031433877489; Email: dominique.disseldorp@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Erasmus Medical Center; Reinier Haga Orthopedisch Centrum; VieCuri Medical Centre; Diakonessenhuis, Utrecht; Flevoziekenhuis; Haga Hospital; Zuyderland Medical Centre; Elkerliek Hospital; Amphia Hospital; Xpert Clinics; Amsterdam UMC
• Investigators: Principal Investigator: Pascal Hannemann, MD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; complications; Cost effectiveness; bone grafting; open wedge osteotomy; time of bone healing; Subjective and objective functional outcomes
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Radius Fractures; Fractures, Malunited
• Other Study ID Numbers: NL68126.068.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No