Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE
Santiago Lozano-Calderon
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.
Description
Bone voids in the skeletal system can result from trauma, infection, surgery, or oncologic disease. If these voids are not treated, they may lead to issues such as pathological fractures, treatment or hardware failure, and recurrence of disease. Various methods exist for addressing bone voids, primarily through the use of grafting materials. Autograft-bone harvested from another part of the same patient and transplanted into the void-is considered the "gold standard" because they fulfill all three criteria of the "ideal" void filler: they are osteoconductive, osteoinductive, and osteogenic. Ho…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
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
Location
- Massachusetts General HospitalBoston, Massachusetts