In’Oss™ (MBCP® Putty) Ortho

• Research type

  Research Study

• Full title

  Study of the osteoconductive potential of the injectable bone substitute In’Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects

• IRAS ID

  307120

• Contact name

  Loïc Limon-Duparcmeur

• Contact email

  loiclimonduparcmeur@biomatlante.com

• Sponsor organisation

  Advanced Medical Solutions Ltd.

• Clinicaltrials.gov Identifier

  NCT06326827

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Worldwide one of the most common types of graft (second only to blood) is bone, with over 500,000 procedures using bone grafting performed annually in the United States, and over 2 million worldwide (Campana et al,.2014) In orthopaedic (bone) and trauma surgery, the filling of bone defects, voids and gaps with bone grafts or bone substitute is performed to prevent bone repair failures.
  In'Oss™ (MCBP Putty), is an Injectable Bone Substitute for surgical use, to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, pelvis).
  The process of bone remodelling is dependent on the implantation site, the volume of filling, the patient’s age, and physical activity.

  The In’Oss™ (MBCP® Putty) device is an Injectable Bone Substitute 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.
  Therefore, in order to improve the clinical data for Injectable Bone Substitute in the orthopaedic application, the sponsor, Advanced Medical Solutions Ltd. (AMS) together with the manufacturer Biomatlante (an AMS company), intend to assess the performance and safety of the device for this purpose.
  100 patients will be enrolled in the study with the use of the In'Oss™ device.
  It is expected that enrolment will take no more than 12 months, with total duration of the study including Patient follow-up expected to be no more than 24 months.
  Patient participation in this study will include a screening visit within 48 hours of admission to hospital, then there will be subsequent clinic visits at: Day of Surgery, Discharge, 3 months (± 7 days), 6 months (± 14 days), and 12 months (± 30 days).

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  24/YH/0217

• Date of REC Opinion

  20 Nov 2024

• REC opinion

  Further Information Favourable Opinion