Health TrialsbyHealthPanel

X-BS Ortho Bone Graft Study

ConditionsOrthopedic DisorderTrauma InjuryExtremity Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAdvanced Medical Solutions Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 bone necrosis either after traumatic injury or elective surgical reconstruction at the surgical site;

Patient has cellulitis;

Patient has granuloma or non-curetted cyst;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: FDBS (GraftR3®)Active comparator 1 intervention
Group B: IBS (MBCP® Putty)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
At 12 months post-surgery

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

Time frame
Within 12 months post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Advanced Medical Solutions Ltd.

Lead sponsor

Advanced Medical Solutions (Nantes)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: