In'Oss™ (MBCP® Putty) Ortho

Study of the Osteoconductive Potential of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) in the Filling of Orthopaedic Bone Defects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Injury; Orthopedic Disorder; Extremity Injury
• Intervention / Treatment: Device: In'Oss™ (MBCP® Putty)

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Susan Clark; Phone Number: 01606863500; Email: susan.clark@admedsol.com
• Study Contact Backup: Name: Loïc Limon-Duparcmeur; Phone Number: 01606863500; Email: loiclimonduparcmeur@biomatlante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

In'Oss™ (MBCP® Putty); 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.

Device: In'Oss™ (MBCP® Putty); Use of In'Oss™ (MBCP® Putty) in 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful bone defect reconstruction in the extremities	Evaluation of performance of the In'Oss™ (MBCP® Putty) through the achievement of successful bone fusion through radiological evaluation (X-Ray) within 12 months by assessing interdigitation in 3 out of 4 planes (anterior/posterior/lateral/medial).	At 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of safety of In'Oss	Incidence of device related Adverse Events after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction in the extremities.	Within 12 months post-surgery
Evaluation of functional mobility restoration in the upper limb with PRO measures	Functional mobility restoration in the upper limb after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction by scoring patient's physical disability and symptoms through patient-reported outcome measure (Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Within 12 months post-surgery
Evaluation of functional mobility restoration in the lower limb with PRO measure	Functional mobility restoration in the lower limb after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction by scoring patient's physical disability and symptoms through patient-reported outcome measure: Lower Extremity Functional Scale (LEFS)	Within 12 months post-surgery
Evaluation of patient's pain intensity with VAS pain scale	Patient's pain intensity at trauma/surgical site evaluated with Visual Analog Scale (VAS) pain scale after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction in the extremities. 0 = no pain; 10 = worst pain imagineable.	Within 12 months post-surgery
Evaluation of device usability	Clinician satisfaction with use of In'Oss™ (MBCP® Putty) as per Instructions for Use (IFU) in bone defect reconstruction in the extremities. 0 = very unsatisfied; 5 = very satisfied.	Within 12 months post-surgery

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Investigators: Principal Investigator: Peter Giannoudis, Leeds General Infirmary, Great George Street Leeds LS1 3EX, United Kingdom

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Fracture; Distal tibia; Proximal humerus; Distal femur; Proximal tibia; Distal radius; MBCP Putty; Bone defect reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases
• Other Study ID Numbers: P231127IBSORTHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No