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

Primary Purpose

Malunion of Fracture of Radius

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Group without bone grafting
Group with bone grafting
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malunion of Fracture of Radius focused on measuring open wedge osteotomy, bone grafting, time of bone healing, complications, Quality of life, Subjective and objective functional outcomes, Cost effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MaastrichtUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with symptomatic malunion of distal radius receiving bone grafting

Patients with symptomatic malunion of distal radius receiving none bone grafts

Arm Description

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

Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.

Outcomes

Primary Outcome Measures

Complications
number and severity during and after the operation
Quality of life using the EQ-5D-5L questionnaire
EQ-5D-5L questionnaire
Time to complete bone healing
Bone healing will be considered complete when the osteotomy gap is filled with bone formation.

Secondary Outcome Measures

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
Subjective functional outcome
Patient-Rated Wrist Evaluation (PRWE) Questionnaire: measure of self-rated wrist pain and disability in activities of daily living
Objective functional outcomes
Active range of motion
Cost effectiveness
cost-effectiveness analysis

Full Information

First Posted
October 10, 2023
Last Updated
October 17, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Haga Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), VieCuri Medical Centre, Zuyderland Medical Centre, Elkerliek Hospital, Erasmus Medical Center, Amphia Hospital, Reinier Haga Orthopedisch Centrum, Flevoziekenhuis, Diakonessenhuis, Utrecht, Xpert Clinics
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1. Study Identification

Unique Protocol Identification Number
NCT06093763
Brief Title
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation
Acronym
WOPPeR
Official Title
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Haga Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), VieCuri Medical Centre, Zuyderland Medical Centre, Elkerliek Hospital, Erasmus Medical Center, Amphia Hospital, Reinier Haga Orthopedisch Centrum, Flevoziekenhuis, Diakonessenhuis, Utrecht, Xpert Clinics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malunion of Fracture of Radius
Keywords
open wedge osteotomy, bone grafting, time of bone healing, complications, Quality of life, Subjective and objective functional outcomes, Cost effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with symptomatic malunion of distal radius receiving bone grafting
Arm Type
Active Comparator
Arm Description
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Arm Title
Patients with symptomatic malunion of distal radius receiving none bone grafts
Arm Type
Active Comparator
Arm Description
Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.
Intervention Type
Procedure
Intervention Name(s)
Group without bone grafting
Intervention Description
Open wedge corrective osteotomy and plate fixation without bone grafting.
Intervention Type
Procedure
Intervention Name(s)
Group with bone grafting
Intervention Description
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
Primary Outcome Measure Information:
Title
Complications
Description
number and severity during and after the operation
Time Frame
follow-up period of at least one year
Title
Quality of life using the EQ-5D-5L questionnaire
Description
EQ-5D-5L questionnaire
Time Frame
follow-up period of one year
Title
Time to complete bone healing
Description
Bone healing will be considered complete when the osteotomy gap is filled with bone formation.
Time Frame
follow-up period of one year
Secondary Outcome Measure Information:
Title
Subjective functional outcomes
Description
Disability of the Arm, Shoulder and Hand Questionnaire (DASH): measure of self-rated upper-extremity disability and symptoms in activities of daily living
Time Frame
follow-up period of one year
Title
Subjective functional outcome
Description
Patient-Rated Wrist Evaluation (PRWE) Questionnaire: measure of self-rated wrist pain and disability in activities of daily living
Time Frame
follow-up period of one year
Title
Objective functional outcomes
Description
Active range of motion
Time Frame
follow-up period of one year
Title
Cost effectiveness
Description
cost-effectiveness analysis
Time Frame
follow-up period of at least one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Disseldorp, MD
Phone
+31648646448
Email
dominique.disseldorp@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Fabienne Hameleers
Phone
+316-29652223
Email
f.hameleers@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Hannemann, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MaastrichtUMC
City
Maastricht
State/Province
Zuid-Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Disseldorp, MD
Phone
+31648646448
Email
dominique.disseldorp@mumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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