An observational study in Cancer of Bone, Trauma and Aseptic Loosening of Orthopaedic Hardware, sponsored by Santiago Lozano-Calderon. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Santiago Lozano-Calderon · Observational
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.
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.
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 10 is below the median of 101 across 82 observational studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →This is the only study on the registry with Santiago Lozano-Calderon as lead sponsor.
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This study will include patients who are 18 years or older and receive Mg OSTEOCRETE™ as bone void filler as a component of their treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Mg OSTEOCRETE is indicated for one of the following reasons:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Mg OSTEOCRETE as a bone void filler
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.
Device: Mg OSTEOCRETE as a bone void filler
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.
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
Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by aseptic loosening of orthopaedic hardware
Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by trauma-related conditions
Time to complete bone remodeling
To determine the time to complete bone remodeling after injection of a magnesium-based bone graft substitute (Mg OSTEOCRETE™), as determined by Hounsfield Units on computed tomography (CT) scan.
Time frame: Pre-operatively through one year after surgery
Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE
To collect safety and efficacy data regarding the performance of Mg OSTEOCRETE™. To longitudinally assess the patient-reported clinical outcomes after injection of a magnesium-based bone graft substitute (Mg OSTEOCRETE™).
Time frame: Pre-operatively through one year after surgery
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
Of 37 observational studies under Bone Neoplasms, half reached primary completion within 192 months of starting (the median), counting those still running; a quarter within 41. This study's planned 24 months is below that.
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