Mg OSTEOCRETE Post-Treatment Outcomes

Официальное название

Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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
• Устройство 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

Первичные конечные точки

• Time to complete bone remodeling [Срок оценки: Pre-operatively through one year after surgery]

Вторичные конечные точки (1)

• Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE [Срок оценки: Pre-operatively through one year after surgery]

Критерии участия

Критерии включения

• 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:

• 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

Критерии исключения

• any contraindication as per Instructions for Use for Mg OSTEOCRETE

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Публикации

• 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
• 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. PMID 17397291
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06720142 · 2024P003397

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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