Evaluating the healing outcomes of Mg OSTEOCRETE for bone defects
Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE
This study is testing a new synthetic bone material called Mg OSTEOCRETE to see if it helps people heal better after surgery for bone defects caused by tumors, injuries, or loose implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06720142 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Mg OSTEOCRETE, a synthetic bone substitute used to fill bone defects resulting from tumor excision, trauma, or loosening of orthopedic hardware. The study aims to assess the healing time and efficacy of Mg OSTEOCRETE through clinical evaluations and patient-reported outcomes. By comparing these outcomes, the research seeks to provide insights into the effectiveness of this alternative to traditional bone grafting methods. Participants will be monitored post-treatment to gather comprehensive data on their recovery process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require Mg OSTEOCRETE for bone voids due to tumors, aseptic loosening of implants, or trauma-related conditions.
Not a fit: Patients with contraindications to Mg OSTEOCRETE as per its Instructions for Use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective alternative for patients with bone defects, reducing complications associated with traditional grafting methods.
How similar studies have performed: While there is growing interest in synthetic bone graft substitutes, the specific use of Mg OSTEOCRETE in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age and older on the day of surgery * has received or will receive Mg OSTEOCRETE as a component of their treatment at this institution in accordance with Instructions for Use for the implanted product * Mg OSTEOCRETE is indicated for one of the following reasons: 1. as a bone void filler following bone tumor resection, or; 2. as an augment for defects causing aseptic loosening of orthopaedic implants, or; 3. to help substitute bone for trauma-related conditions Exclusion Criteria: * any contraindication as per Instructions for Use for Mg OSTEOCRETE
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Santiago A Lozano-Calderon, MD, PhD — Massachusetts General Hospital
- Study coordinator: Shreya Halur, BS
- Email: shalur@mgh.harvard.edu
- Phone: 617-726-4932
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.