Not Yet RecruitingNot Applicable

In'Oss™ (MBCP® Putty) Ortho

100 participantsStarted 2025-03

Plain-language summary

Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patient is male or female, 18 - 85 years old;
✓. Patient is willing and able to give written informed consent;
✓. Patient is able to comply with a prior medical examination;
✓. Patient is or has been scheduled for a surgical procedure to correct epiphyso-metaphyseal and/or metaphyso-diaphyseal bone defect in one of the following anatomical locations:
✓. Patient is willing and able to comply with the study procedures during surgery and the post-surgical follow up period, up to 12 months.

Exclusion criteria

✕. Patient has had an infection in the same extremity within last 24 months;
✕. Patient has signs of necrosis at the surgical site;
✕. Patient has cellulitis;
✕. Patient has granuloma or non-curetted cyst;
✕. Patient has an history of uncontrolled diabetes;
✕. Patient is alcoholic and/or heavy smoker (\> 20 cigarettes per day);
✕. Patient has a congenital or acquired immunodeficiency;
✕. Patient has severe bone loss (≥ 40cm3);

What they're measuring

Successful bone defect reconstruction in the extremities

Timeframe: At 12 months post-surgery

Trial details

NCT IDNCT06326827

SponsorAdvanced Medical Solutions Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Susan Clark

01606863500 susan.clark@admedsol.com

View on ClinicalTrials.gov More Orthopedic Disorder trials