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Orthopedic DisorderNCT06326827

X-BS Ortho Bone Graft Study

A study testing FDBS (GraftR3®) and IBS (MBCP® Putty) in people with Orthopedic Disorder and Trauma Injury, run by Advanced Medical Solutions Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
FDBS (GraftR3®) and IBS (MBCP® Putty)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Oct 2026to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 void in one of the following anatomical locations either after traumatic injury or elective surgical reconstruction:
  • 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.

Who cannot join

  • Patient has had an infection in the same extremity within last 24 months;
  • Patient has bone necrosis either after traumatic injury or elective surgical reconstruction at the surgical site;
  • Patient has cellulitis;
  • Patient has granuloma or non-curetted cyst;
  • Patient has a current or previous diagnosis of osteomyelitis;
  • Patient has a clinically significant degenerative bone disease;
Show all 19Show fewer
  • 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 void (cavity) 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 or breastfeeding;
  • Patient who is an employee at the study site;
  • Patient is known to be non-compliant with medical treatment or follow-up
  • 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;
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Loïc Limon-Duparcmeur contact

01606863500

loiclimonduparcmeur@admedsol.com

Susan Clark contact

01606863500

susan.clark@admedsol.com

About this study

Official title: Randomised Investigation of the Osteoconductive Performance and Safety of FDBS Bone Graft, With Contextual Reference to IBS, in the Filling of Orthopaedic Bone Defects.

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.

Read the detailed description

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.

Being tested
FDBS (GraftR3®), IBS (MBCP® Putty)
Keywords
Proximal humerus, Distal radius, Distal femur, Proximal tibia, Distal tibia, Fracture, MBCP Putty, Bone defect reconstruction, GraftR3
Medical subject headings
Musculoskeletal Diseases, Accidental Injuries, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDBS (GraftR3®)Device

    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.

  • IBS (MBCP® Putty)Device

    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.

Study groups in NCT06326827
Study groupRoleWhat they receive
FDBS (GraftR3®)Active comparatorThe 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.
Receives: Device: FDBS (GraftR3®)
IBS (MBCP® Putty)Active comparatorThe 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
Receives: Device: IBS (MBCP® Putty)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At 12 months post-surgery

Secondary outcomes (6)

  1. 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

    Measured: Within 12 months post-surgery

  2. 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

    Measured: Within 12 months post-surgery

  3. 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

    Measured: Within 12 months post-surgery

  4. 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

    Measured: Within 12 months post-surgery

  5. 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

    Measured: Within 12 months post-surgery

  6. 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

    Measured: At 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06326827
Sponsor's protocol ID
STD-030-001
Status last verified
Sep 2026
First submitted
18 Mar 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FDBS (GraftR3®) and IBS (MBCP® Putty) in people with Orthopedic Disorder and Trauma Injury, run by Advanced Medical Solutions Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Loïc Limon-Duparcmeur (01606863500, loiclimonduparcmeur@admedsol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of performance and safety of FDBS and IBS in the reconstruction of bone voids in the extremities (time frame: At 12 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06326827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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X-BS Ortho Bone Graft Study (NCT06326827) | AzTrials