In'Oss™ (MBCP® Putty) Ortho
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAdvanced Medical Solutions Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Proximal humerus ▪ Distal radius
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
In'Oss™ (MBCP® Putty)
DeviceUse 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: In'Oss™ (MBCP® Putty)1 intervention
Trial outcomes
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).
Time frame
At 12 months post-surgerySecondary outcomes
1
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)
Time frame
Within 12 months post-surgery2
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)
Time frame
Within 12 months post-surgery3
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.
Time frame
Within 12 months post-surgery4
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.
Time frame
Within 12 months post-surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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