In'Oss™ (MBCP® Putty) Ortho

NCT06326827 | Not Yet Recruiting

• 1 other identifier: P231127IBSORTHO
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Orthopedic Disorder; Trauma Injury; Extremity Injury

Keywords

Proximal humerus; Distal radius; Distal femur; Proximal tibia; Distal tibia; Fracture; MBCP Putty; Bone defect reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of functional mobility restoration in the upper limb with PRO measures

  Within 12 months post-surgery

• Evaluation of functional mobility restoration in the lower limb with PRO measure

  Within 12 months post-surgery

• Evaluation of patient's pain intensity with VAS pain scale

  Within 12 months post-surgery

• Evaluation of safety of In'Oss

  Within 12 months post-surgery

• Evaluation of device usability

  Within 12 months post-surgery

Study Arms (1)

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)

Interventions

In'Oss™ (MBCP® Putty) DEVICE

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.

In'Oss™ (MBCP® Putty)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Proximal humerus ▪ Distal radius
• Distal femur ▪ Proximal tibia ▪ Distal tibia
• Patient is willing and able to comply with the study procedures during surgery and the post-surgical follow up period, up to 12 months.

You may not qualify if:

• 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);
• Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism;
• Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device;
• Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created;
• 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;
• Patient is pregnant;
• Patient who is an employee at the study site;
• Patient is known to be non-compliant with medical treatment or follow-up

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

MeSH Terms

Conditions

Musculoskeletal Diseases; Accidental Injuries; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Peter Giannoudis

  Leeds General Infirmary, Great George Street Leeds LS1 3EX, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Clark

CONTACT

01606863500; susan.clark@admedsol.com

Loïc Limon-Duparcmeur

CONTACT

01606863500; loiclimonduparcmeur@biomatlante.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share