[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06720142":3,"trial-entities:NCT06720142":125,"trial-summary:NCT06720142":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":15,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":51,"sex":55,"minimum_age":56,"maximum_age":15,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":90,"references":93,"see_also_links":124},"NCT06720142","2024P003397","Mg OSTEOCRETE Post-Treatment Outcomes","Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE","RECRUITING","2028-03-17","2026-04","2026-04-22","2025-03-17","Santiago Lozano-Calderon","OTHER",null,"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.\n\nDue 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).\n\nMg OSTEOCRETE™ is a moldable\u002Finjectable 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.",[19,20,21],"Cancer of Bone","Trauma","Aseptic Loosening of Orthopaedic Hardware",[23,24,25],"bone defect","bone substitute","osteocrete","OBSERVATIONAL",[],{"count":29,"type":30},10,"ESTIMATED",[32,38,42],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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",[37],"Bone void following bone tumor resection",{"type":33,"name":34,"description":39,"armGroupLabels":40},"Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by aseptic loosening of orthopaedic hardware",[41],"Bone defect caused by aseptic loosening of orthopaedic implants",{"type":33,"name":34,"description":43,"armGroupLabels":44},"Patients will be treated with Mg OSTEOCRETE as per standard clinical care to fill defects in bone left by trauma-related conditions",[45],"Bone defect caused by trauma-related condition",[47],{"measure":48,"description":49,"timeFrame":50},"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",[52],{"measure":53,"description":54,"timeFrame":50},"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™).","ALL","18 Years",false,{"inclusion":59,"exclusion":63,"raw_text":65},[60,61,62],"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:",[64],"any contraindication as per Instructions for Use for Mg OSTEOCRETE","Inclusion Criteria:\n\n* 18 years of age and older on the day of surgery\n* 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\n* Mg OSTEOCRETE is indicated for one of the following reasons:\n\n  1. as a bone void filler following bone tumor resection, or;\n  2. as an augment for defects causing aseptic loosening of orthopaedic implants, or;\n  3. to help substitute bone for trauma-related conditions\n\nExclusion Criteria:\n\n* any contraindication as per Instructions for Use for Mg OSTEOCRETE",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Shreya Halur, BS","CONTACT","617-726-4932","shalur@mgh.harvard.edu",{"lat":83,"lon":84},42.35843,-71.05977,[86,87],{"name":78,"role":79,"phone":80,"email":81},{"name":88,"role":79,"phone":89},"Santiago A Lozano-Calderon, MD, PhD","617-643-4947",[91],{"name":88,"affiliation":71,"role":92},"PRINCIPAL_INVESTIGATOR",[94,98,100,103,106,109,112,115,118,121],{"pmid":95,"type":96,"citation":97},"18662897","BACKGROUND","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\u002Fj.actbio.2008.06.020. Epub 2008 Jul 10.",{"type":96,"citation":99},"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\u002F23312025.2018.1487255.",{"pmid":101,"type":96,"citation":102},"17397291","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\u002Fajvr.68.4.370.",{"pmid":104,"type":96,"citation":105},"18319348","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\u002F0363546508314396. Epub 2008 Mar 4.",{"pmid":107,"type":96,"citation":108},"24512978","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\u002Fj.actbio.2014.02.002. Epub 2014 Feb 7.",{"pmid":110,"type":96,"citation":111},"28798480","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\u002Fs41598-017-08379-y.",{"pmid":113,"type":96,"citation":114},"22043972","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\u002Fjlongtermeffmedimplants.v21.i2.40.",{"pmid":116,"type":96,"citation":117},"18829901","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\u002FJBJS.G.01191.",{"pmid":119,"type":96,"citation":120},"21431354","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\u002Fs10856-011-4272-0. Epub 2011 Mar 23.",{"pmid":122,"type":96,"citation":123},"31809394","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\u002FJBJS.19.00680.",[],{"nct_id":4,"conditions":126,"biomarkers":130},[21,127,128,129],"Bone defects","Bone Trauma","Malignant Bone Neoplasm",[],{"nct_id":4,"found":132,"summary":133,"prompt_version":143},true,{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This is an observational study that plans to include 10 participants. It is not a randomized or blinded study.","completed","Observational Study of Mg OSTEOCRETE for Bone Repair","This study is looking at how well a bone void filler called Mg OSTEOCRETE works in people who have bone defects from cancer, trauma, or loose orthopedic hardware. Mg OSTEOCRETE is a material used to fill gaps in bone after surgery. Researchers want to understand how long it takes for bone to heal completely after using Mg OSTEOCRETE. They will also look at how patients feel and how well the treatment works in real-world settings. You may be able to join if you are 18 or older and have received or will receive Mg OSTEOCRETE as part of your treatment for one of these conditions. This is an observational study, meaning researchers will watch and collect information about your care as it happens.","Participants will be followed from before surgery through one year after surgery to measure bone healing.",123,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]