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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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