Mg OSTEOCRETE Post-Treatment Outcomes

NCT06720142 | Recruiting FDA Device

• 1 other identifier: 2024P003397
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of Bone; Trauma; Aseptic Loosening of Orthopaedic Hardware

Keywords

bone defect; bone substitute; osteocrete

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-operatively through one year after surgery

Secondary Outcomes (1)

• Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE

  Pre-operatively through one year after surgery

Study Arms (3)

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.

Device: Mg OSTEOCRETE as a bone void filler

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.

Device: Mg OSTEOCRETE as a bone void filler

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.

Device: Mg OSTEOCRETE as a bone void filler

Interventions

Mg OSTEOCRETE as a bone void filler DEVICE

Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by bone tumor resection

Bone void following bone tumor resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• any contraindication as per Instructions for Use for Mg OSTEOCRETE

Sponsors & Collaborators

• Santiago Lozano-Calderon: lead
• Bone Solutions Inc: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 18662897 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17397291 BACKGROUND

• 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.

  PMID: 18319348 BACKGROUND

• 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.

  PMID: 24512978 BACKGROUND

• 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.

  PMID: 28798480 BACKGROUND

• 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.

  PMID: 22043972 BACKGROUND

• 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.

  PMID: 18829901 BACKGROUND

• 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.

  PMID: 21431354 BACKGROUND

• 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.

  PMID: 31809394 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Wounds and Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Santiago A Lozano-Calderon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreya Halur, BS

CONTACT

617-726-4932; shalur@mgh.harvard.edu

Santiago A Lozano-Calderon, MD, PhD

CONTACT

617-643-4947

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Orthopaedic Surgeon/Assistant Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)