Clinical trial NCT06720142: Mg OSTEOCRETE Post-Treatment Outcomes
Official title: Clinical and Radiographic Outcomes of Patients Treated With Mg OSTEOCRETE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Bone
Trauma
Aseptic Loosening of Orthopaedic Hardware
Keywords: bone defect
bone substitute
osteocrete
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Alliant Biotech, LLC
First posted: 2024-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  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:

* any contraindication as per Instructions for Use for Mg OSTEOCRETE

Primary outcomes:
measure: Time to complete bone remodeling
timeFrame: Pre-operatively through one year after surgery
Secondary outcomes:
measure: Survey of patient-reported outcomes and safety and efficacy of OSTEOCRETE
timeFrame: Pre-operatively through one year after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Santiago A Lozano-Calderon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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