Study Results
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Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2025-03-17
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bone Solutions Inc
UNKNOWN
Santiago Lozano-Calderon
OTHER
Responsible Party
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Santiago Lozano-Calderon
Attending Orthopaedic Surgeon/Assistant Professor
Principal Investigators
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Santiago A Lozano-Calderon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Santiago A Lozano-Calderon, MD, PhD
Role: CONTACT
Facility Contacts
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References
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Wu F, Wei J, Guo H, Chen F, Hong H, Liu C. Self-setting bioactive calcium-magnesium phosphate cement with high strength and degradability for bone regeneration. Acta Biomater. 2008 Nov;4(6):1873-84. doi: 10.1016/j.actbio.2008.06.020. Epub 2008 Jul 10.
Zhang Z., Yang Z., Chen Z., et al. A study on bone cement containing magnesium potassium phosphate for bone repair. Cogent Biol 2018;4(1):1487255. Doi: 10.1080/23312025.2018.1487255.
Waselau M, Samii VF, Weisbrode SE, Litsky AS, Bertone AL. Effects of a magnesium adhesive cement on bone stability and healing following a metatarsal osteotomy in horses. Am J Vet Res. 2007 Apr;68(4):370-8. doi: 10.2460/ajvr.68.4.370.
Gulotta LV, Kovacevic D, Ying L, Ehteshami JR, Montgomery S, Rodeo SA. Augmentation of tendon-to-bone healing with a magnesium-based bone adhesive. Am J Sports Med. 2008 Jul;36(7):1290-7. doi: 10.1177/0363546508314396. Epub 2008 Mar 4.
Yoshizawa S, Brown A, Barchowsky A, Sfeir C. Magnesium ion stimulation of bone marrow stromal cells enhances osteogenic activity, simulating the effect of magnesium alloy degradation. Acta Biomater. 2014 Jun;10(6):2834-42. doi: 10.1016/j.actbio.2014.02.002. Epub 2014 Feb 7.
Diaz-Tocados JM, Herencia C, Martinez-Moreno JM, Montes de Oca A, Rodriguez-Ortiz ME, Vergara N, Blanco A, Steppan S, Almaden Y, Rodriguez M, Munoz-Castaneda JR. Magnesium Chloride promotes Osteogenesis through Notch signaling activation and expansion of Mesenchymal Stem Cells. Sci Rep. 2017 Aug 10;7(1):7839. doi: 10.1038/s41598-017-08379-y.
Pernaa K, Koski I, Mattila K, Gullichsen E, Heikkila J, Aho A, Lindfors N. Bioactive glass S53P4 and autograft bone in treatment of depressed tibial plateau fractures - a prospective randomized 11-year follow-up. J Long Term Eff Med Implants. 2011;21(2):139-48. doi: 10.1615/jlongtermeffmedimplants.v21.i2.40.
Russell TA, Leighton RK; Alpha-BSM Tibial Plateau Fracture Study Group. Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study. J Bone Joint Surg Am. 2008 Oct;90(10):2057-61. doi: 10.2106/JBJS.G.01191.
Heikkila JT, Kukkonen J, Aho AJ, Moisander S, Kyyronen T, Mattila K. Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study. J Mater Sci Mater Med. 2011 Apr;22(4):1073-80. doi: 10.1007/s10856-011-4272-0. Epub 2011 Mar 23.
Hofmann A, Gorbulev S, Guehring T, Schulz AP, Schupfner R, Raschke M, Huber-Wagner S, Rommens PM; CERTiFy Study Group. Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study. J Bone Joint Surg Am. 2020 Feb 5;102(3):179-193. doi: 10.2106/JBJS.19.00680.
Other Identifiers
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2024P003397
Identifier Type: -
Identifier Source: org_study_id
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