In'Oss™ (MBCP® Putty) Ortho

Advanced Medical Solutions

Status: Not yet enrolling

Conditions: Orthopedic Disorder; Trauma Injury; Extremity Injury

Treatments: Device: In'Oss™ (MBCP® Putty)

Study type: Observational

Funder types: Industry

Identifiers

NCT06326827

P231127IBSORTHO

Details and patient eligibility

About

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

Full description

The In'Oss™ (MBCP® Putty) device is an Injectable Bone Substitute (IBS) whose purpose is a bone gap and void filler. It forms a putty-like synthetic bone graft which molds to the shape of the defect. It is composed of Hydroxyapatite (HA), Beta Tricalcium Phosphate (ß-TCP) and a hydrogel and is presented in sterile syringes.

The Injectable Bone Substitute In'Oss™ is intended for use to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis). The performances of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process).

The purpose of this study is primarily to collect Post-Market Clinical Follow-up (PMCF) data on the performance and safety of the CE marked In'Oss™ device in the orthopaedic application. The data and conclusions obtained from this study by the Sponsor Advanced Medical Solutions Ltd. (AMS) together with the manufacturer Biomatlante will be used to provide clinical evidence for the clinical evaluation process.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is male or female, 18 - 85 years old;

2. Patient is willing and able to give written informed consent;

3. Patient is able to comply with a prior medical examination;

4. 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:

   • Proximal humerus ▪ Distal radius
   • Distal femur ▪ Proximal tibia ▪ Distal tibia

5. 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

1. Patient has had an infection in the same extremity within last 24 months;
2. Patient has signs of necrosis at the surgical site;
3. Patient has cellulitis;
4. Patient has granuloma or non-curetted cyst;
5. Patient has an history of uncontrolled diabetes;
6. Patient is alcoholic and/or heavy smoker (> 20 cigarettes per day);
7. Patient has a congenital or acquired immunodeficiency;
8. Patient has severe bone loss (≥ 40cm3);
9. Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism;
10. Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device;
11. Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created;
12. Patient was exposed to any radiation (e.g. X-Rays, handling of radiolabelled materials) other than the normal background radiation within the 12 months before the screening visit;
13. Patient is pregnant;
14. Patient who is an employee at the study site;
15. Patient is known to be non-compliant with medical treatment or follow-up
16. Patient has any significant or unstable medical/psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study;
17. Patient is currently enrolled or planning to enrol in another clinical study or treatment with another investigational drug/device that may interfere with the assessments, visits or outcomes of this study.

Trial design

100 participants in 1 patient group

In'Oss™ (MBCP® Putty)

Description:

Participants will be recruited from a population who are undergoing orthopaedic bone trauma surgery at the investigational site. All admitted patients will be screened and assessed to determine whether patients may be eligible to take part based on the inclusion and exclusion criteria. Patient participation in this study will include a screening visit within 48 hours of admission to hospital prior the surgery.

Treatment:

Device: In'Oss™ (MBCP® Putty)