Clinical trial NCT06326827: In'Oss™ (MBCP® Putty) Ortho
Official title: Study of the Osteoconductive Potential of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) in the Filling of Orthopaedic Bone Defects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthopedic Disorder
Trauma Injury
Extremity Injury
Keywords: Proximal humerus
Distal radius
Distal femur
Proximal tibia
Distal tibia
Fracture
MBCP Putty
Bone defect reconstruction
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to include 100 adult patients male and female to be enrolled in this study. The sample size is based on formal calculations to demonstrate effectiveness (see section 10 for detail). The Sponsor expects to enrol 100% of the patients at one (1) investigational site in the UK.

All adults aged between 18 to 85 years old will be screened for the study. If the patients meet all inclusion criteria, but none of the exclusion criteria, the patients will be asked to participate in this study.

Prior to enrolment in this study, all patients will undergo a general medical evaluation to assess co-morbidities, and risk factors associated with their disease. All patients must be fit for anaesthetic and surgery.

In cases where it is not possible for subjects to provide written informed consent prior to surgery, screening (Visit 1) assessments will be performed as soon as possible after surgery (no later than 48 hours after surgery), after written informed consent has been obtained.

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful bone defect reconstruction in the extremities
timeFrame: At 12 months post-surgery
Secondary outcomes:
measure: Evaluation of functional mobility restoration in the upper limb with PRO measures
timeFrame: Within 12 months post-surgery
measure: Evaluation of functional mobility restoration in the lower limb with PRO measure
timeFrame: Within 12 months post-surgery
measure: Evaluation of patient's pain intensity with VAS pain scale
timeFrame: Within 12 months post-surgery
measure: Evaluation of safety of In'Oss
timeFrame: Within 12 months post-surgery
measure: Evaluation of device usability
timeFrame: Within 12 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Leeds General Infirmary, Great George Street Leeds LS1 3EX, United Kingdom
name: Peter Giannoudis
role: PRINCIPAL_INVESTIGATOR
References: