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Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Mg OSTEOCRETE is a bone substitute used to fill a defect in bone caused by excision of a tumor, orthopaedic hardware that has become loosened, or a trauma-related condition. The aim of this study is to determine the amount of time it takes for bone to heal after treatment with Mg OSTEOCRETE, and to better understand the efficacy of this treatment through clinical and patient-reported outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ as a bone void filler following bone tumor resection, or;

⁃ as an augment for defects causing aseptic loosening of orthopaedic implants, or;

⁃ to help substitute bone for trauma-related conditions

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Shreya Halur, BS
shalur@mgh.harvard.edu
617-726-4932
Backup
Santiago A Lozano-Calderon, MD, PhD
617-643-4947
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2026-06
Participants
Target number of participants: 10
Treatments
Bone void following bone tumor resection
Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints.
Bone defect caused by aseptic loosening of orthopaedic implants
Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints.
Bone defect caused by trauma-related condition
Patients are being targeted because they have already agreed to receive OSTEOCRETE as part of standard clinical care. They will complete surveys, blood draws to test for magnesium levels, and low-dose CT scans at various post-operative timepoints.
Related Therapeutic Areas
Sponsors
Collaborators: Bone Solutions Inc
Leads: Santiago Lozano-Calderon

This content was sourced from clinicaltrials.gov