Health TrialsbyHealthPanel

Mg OSTEOCRETE Post-Treatment Outcomes

ConditionsCancer of BoneTraumaAseptic Loosening of Orthopaedic Hardware
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSantiago Lozano-Calderon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

as a bone void filler following bone tumor resection, or;

as an augment for defects causing aseptic loosening of orthopaedic implants, or;

Disqualifiers

any contraindication as per Instructions for Use for Mg OSTEOCRETE

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • 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 aseptic loosening of orthopaedic hardware

  • 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 trauma-related conditions

Treatment groups

10 Participants
are divided into 3 treatment groups
Group A: Bone void following bone tumor resection1 intervention
Group B: Bone defect caused by aseptic loosening of orthopaedic implants1 intervention
Group C: Bone defect caused by trauma-related condition1 intervention

Trial outcomes

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.

Time frame
Pre-operatively through one year after surgery

Secondary outcomes

1

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™).

Time frame
Pre-operatively through one year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Santiago Lozano-Calderon

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Bone Solutions Inc

Collaborator

Source ClinicalTrials.gov
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