NCT06720142

Mg OSTEOCRETE Post-Treatment Outcomes

Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Santiago Lozano-Calderon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. However, their use can be limited by availability and potential donor site complications, with up to 39% of patients reporting pain at the donor site. Due to concerns with traditional bone grafting methods, there is growing interest in alternative options. While allografts carry a risk of disease transmission and xenografts are prone to immune rejection, synthetic bone graft substitutes offer a promising alternative. These substitutes, made from materials like calcium sulfate or calcium phosphate, address many issues associated with autografts and allografts. With improved understanding of their performance post-implantation, ongoing advancements are being made. This Clinical Investigation Plan outlines an observational study to evaluate clinical and radiographic outcomes with a particular synthetic bone graft substitute (Mg OSTEOCRETE™; Alliant Biotech, LLC; Grand Rapids, MI). Mg OSTEOCRETE™ is a moldable/injectable magnesium-based void filler that provides stability while also increasing cell proliferation. Use of Mg OSTEOCRETE™ has been shown to advance the rate of mineralization with a result of enhanced bone regeneration for multiple types of orthopedic applications.

Conditions

• Cancer of Bone
• Trauma
• Aseptic Loosening of Orthopaedic Hardware

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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
DEVICE	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

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-12-06
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study