Mg OSTEOCRETE Post-Treatment Outcomes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Santiago Lozano-Calderon
Study ID
NCT06720142
Status
Recruiting
Apply to this trial

Conditions

  • Aseptic Loosening of Orthopaedic Hardware
  • Cancer of Bone
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Apr 2026
Primary completion
Mar 17, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

  • Shreya Halur, BS
    617-726-4932
    [email protected]
  • Santiago A Lozano-Calderon, MD, PhD
    617-643-4947

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Shreya Halur, BS
[email protected]
617-726-4932

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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