Recruiting

Mg OSTEOCRETE

Sponsor:

Santiago Lozano-Calderon

Code:

NCT06720142

Conditions

Cancer of Bone

Trauma

Aseptic Loosening of Orthopaedic Hardware

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mg OSTEOCRETE as a bone void filler

Mg OSTEOCRETE as a bone void filler

Mg OSTEOCRETE as a bone void filler

Study Details

Brief 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.

Conditions

Cancer of Bone

Trauma

Aseptic Loosening of Orthopaedic Hardware

Study ID

NCT06720142

Start date

Mar 17, 2025

Status verified date

Apr, 2026

Completion date

Mar 17, 2028

Anticipated

Primary completion date

Mar 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Mg OSTEOCRETE as a bone void filler

Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by bone tumor resection

Mg OSTEOCRETE as a bone void filler

Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by aseptic loosening of orthopaedic hardware

Mg OSTEOCRETE as a bone void filler

Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by trauma-related conditions

Primary outcome measure

  • Time to complete bone remodeling [ Time Frame: Pre-operatively through one year after surgery ]

Central Contacts and Locations

Central contacts

Shreya Halur, BS

617-726-4932shalur@mgh.harvard.edu

Santiago A Lozano-Calderon, MD, PhD

617-643-4947

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Shreya Halur, BS

617-726-4932shalur@mgh.harvard.edu

More Information

Sponsor

Santiago Lozano-Calderon

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • bone defect
  • bone substitute
  • osteocrete

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Santiago Lozano-Calderon on 2026-04-22.