RecruitingNCT06720142

Mg OSTEOCRETE Post-Treatment Outcomes

Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE


Sponsor

Santiago Lozano-Calderon

Enrollment

10 participants

Start Date

Mar 17, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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

Exclusion Criteria1

  • any contraindication as per Instructions for Use for Mg OSTEOCRETE

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Interventions

DEVICEMg 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

DEVICEMg 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

DEVICEMg 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


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06720142


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