Evaluating bone grafts in corrective surgery for wrist fractures
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures
This study tests if using bone grafts during wrist surgery helps people with poorly healed fractures recover better and have fewer problems than those who don't get grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Zuid-Limburg) |
| Trial ID | NCT06093763 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using bone grafts during open wedge corrective osteotomy and plate fixation for patients with malunion of the distal radius. It compares outcomes between patients receiving bone grafts and those who do not, focusing on bone healing time and potential complications. The research aims to determine if bone grafting is necessary or if it poses more risks than benefits for patients. The study will follow participants for at least 12 months post-surgery to assess their recovery and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic malunion of the distal radius who are eligible for corrective osteotomy.
Not a fit: Patients who are pregnant or have systemic disorders affecting bone health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the necessity of bone grafting, potentially reducing complications and improving recovery for patients.
How similar studies have performed: Other studies have explored bone grafting in orthopedic procedures, but this specific comparison of grafting necessity in distal radius malunion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maastricht, Zuid-Limburg
- MaastrichtUMC — Maastricht, Zuid-Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Pascal Hannemann, MD — Maastricht University Medical Center
- Study coordinator: Dominique Disseldorp, MD
- Email: dominique.disseldorp@mumc.nl
- Phone: 0031433877489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.