Malunion of Fracture of RadiusWOPPeRNCT06093763
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation
A study testing Group without bone grafting and Group with bone grafting in people with Malunion of Fracture of Radius, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malunion of Fracture of Radius
- What is being tested?
- Group without bone grafting and Group with bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are pregnant
- Patients who have known systemic or metabolic disorders leading to progressive bone deterioration
- Patients who take chronic use of glucocorticoids.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
MaastrichtUMC
Maastricht, Zuid-Limburg, 6229 HX
Dominique Disseldorp, MD, 0031433877489, dominique.disseldorp@mumc.nl
About this study
Official title: 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.
Read more
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
- Being tested
- Group without bone grafting, Group with bone grafting
- Keywords
- open wedge osteotomy, bone grafting, time of bone healing, complications, Quality of life, Subjective and objective functional outcomes, Cost effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group without bone graftingProcedure or surgery
Open wedge corrective osteotomy and plate fixation without bone grafting.
Group with bone graftingProcedure or surgery
Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic malunion of distal radius receiving bone grafting | Active comparator | Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. Receives: Procedure: Group with bone grafting |
| Patients with symptomatic malunion of distal radius receiving none bone grafts | Active comparator | Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest. Receives: Procedure: Group without bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
number and severity during and after the operation
Measured: follow-up period of at least one year
Quality of life using the EQ-5D-5L questionnaire
EQ-5D-5L questionnaire
Measured: 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.
Measured: follow-up period of one year
Secondary outcomes (4)
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
Measured: 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
Measured: follow-up period of one year
Objective functional outcomes
Active range of motion
Measured: follow-up period of one year
Cost effectiveness
cost-effectiveness analysis
Measured: follow-up period of at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malunion of Fracture of RadiusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Haga Hospital, Amsterdam UMC, VieCuri Medical Centre, Zuyderland Medical Centre, Elkerliek Hospital, Erasmus Medical Center, Amphia Hospital, Reinier Haga Orthopedisch Centrum, Flevoziekenhuis, Diakonessenhuis, Utrecht, Xpert Clinics
- Responsible party
- Sponsor
- Investigators
- Pascal Hannemann, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093763
- Sponsor's protocol ID
- NL68126.068.18
- Acronym
- WOPPeR
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT06093763
- Acronym / sponsor ID
- WOPPeR / NL68126.068.18
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Haga Hospital, Amsterdam UMC, VieCuri Medical Centre, Zuyderland Medical Centre, Elkerliek Hospital, Erasmus Medical Center, Amphia Hospital, Reinier Haga Orthopedisch Centrum, Flevoziekenhuis, Diakonessenhuis, Utrecht, Xpert Clinics
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic malunion of distal radius receiving bone grafting | Active comparator | Procedure: Group with bone graftingOpen wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. |
| Patients with symptomatic malunion of distal radius receiving none bone grafts | Active comparator | Procedure: Group without bone graftingOpen wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who are pregnant
- Patients who have known systemic or metabolic disorders leading to progressive bone deterioration
- Patients who take chronic use of glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group without bone graftingOpen wedge corrective osteotomy and plate fixation without bone grafting. | Procedure or surgery | Patients with symptomatic malunion of distal radius receiving none bone grafts |
| Group with bone graftingOpen wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest. | Procedure or surgery | Patients with symptomatic malunion of distal radius receiving bone grafting |
Primary outcome
Complications
Time frame: 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
Time frame: follow-up period of one year
EQ-5D-5L questionnaire
Time to complete bone healing
Time frame: follow-up period of one year
Bone healing will be considered complete when the osteotomy gap is filled with bone formation.
4 secondary outcomes
Subjective functional outcomes
Time frame: follow-up period of one year
Subjective functional outcome
Time frame: follow-up period of one year
Objective functional outcomes
Time frame: follow-up period of one year
Cost effectiveness
Time frame: follow-up period of at least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Hannemann, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group without bone grafting and Group with bone grafting in people with Malunion of Fracture of Radius, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Disseldorp, MD (0031433877489, dominique.disseldorp@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: follow-up period of at least one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.