An interventional study of FDBS (GraftR3®) and IBS (MBCP® Putty) in Orthopedic Disorder, Trauma Injury and Extremity Injury, sponsored by Advanced Medical Solutions Ltd.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Advanced Medical Solutions Ltd. · Not applicable, Interventional, and Treatment
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
The primary purpose of this study is to collect clinical investigation data on the performance and safety of the CE-marked FDBS bone graft (GraftR3®) for the reconstruction of bony voids or bone gaps, in orthopaedic applications that are not intrinsic to the stability of the bone structure. It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue.
The study is sponsored by Advanced Medical Solutions (Nantes) and will provide essential clinical evidence to support the clinical evaluation of FDBS (GraftR3®).
For contextual interpretation, a reference arm including IBS (MBCP® Putty), a CE-marked bone substitute with established conformity to the relevant essential requirements, has been incorporated. This will allow descriptive comparison with a marketed product while maintaining the primary focus on the CE-marked device FDBS.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 200 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Advanced Medical Solutions Ltd. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Patient is or has been scheduled for a surgical procedure to correct epiphyso-metaphyseal and/or metaphyso-diaphyseal bone void in one of the following anatomical locations either after traumatic injury or elective surgical reconstruction:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The CE-marked device FDBS (GraftR3®) is a powder that presents an interconnected network that enables the colonization of bone cells and biological fluid uniformly within the matrix required for the biological exchanges particularly for bone ingrowth. It is intended for the reconstruction of bony voids or bone gaps in orthopaedic applications that are not intrinsic to the stability of the bone structure. It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue. The clinical investigation is designed to generate data on the performance and safety of FDBS in orthopaedic trauma surgery.
Device: FDBS (GraftR3®)
The CE-marked device IBS (MBCP® Putty) is an injectable bone substitute to fill and reconstruct bone voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis). It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue. For contextual interpretation, the study will include patients treated with this technology, as published data remain limited for certain indications such as surgically created bone defects (e.g. post cyst removal) or bone gaps due to traumatic injury
Device: IBS (MBCP® Putty)
Use of FDBS (GraftR3®) 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.
Use of IBS (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.
Evaluation of performance and safety of FDBS and IBS in the reconstruction of bone voids in the extremities
Achievement of successful bone integration (without occurrence of Major Adverse Events) through radiological evaluation within 12 months by assessing interdigitation in 3 out of 4 anatomical planes (anterior/posterior/lateral/medial)
Time frame: At 12 months post-surgery
Evaluation of device-related Adverse Events associated with FDBS and IBS in the reconstruction of bone voids in the extremities
Incidence of device related Adverse Events
Time frame: Within 12 months post-surgery
Functional evaluation after use of FDBS and IBS in the reconstruction of bone voids in the upper extremities
Functional mobility restoration by scoring patient's physical disability and symptoms through QuickDASH outcome measure
Time frame: Within 12 months post-surgery
Functional evaluation after use of FDBS and IBS in the reconstruction of bone voids in the lower extremities
Functional mobility restoration by scoring patient's physical disability and symptoms through LEFS outcome measure
Time frame: Within 12 months post-surgery
Evaluation of subject's pain after use of FDBS and IBS in the reconstruction of bone voids in the extremities
Patient's pain intensity at trauma/surgical site 0 = no pain; 10 = worst pain imagineable
Time frame: Within 12 months post-surgery
Evaluation of usability of FDBS and IBS in the reconstruction of bone voids in the extremities
Clinician satisfaction with use of FDBS and IBS as per IFU
Time frame: Within 12 months post-surgery
Evaluation of the difference in performance of FDBS versus IBS in the reconstruction of bone defects in the extremities
Difference between FDBS and IBS in successful rates of bone integration through radiological evaluation at 12 months
Time frame: At 12 months post-surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 266 interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 12 months is below that.
Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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