Clinical trials: Bone Substitutes
Bone Deformity
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical…
- Trial name
- ROSA (NCT03570606)
- Testing
- bone graft substitute
- Where
- 7 sites in United Kingdom
- Volunteers
- 220 people
- Sponsor
- Ceramisys Ltd
Alveolar Ridge Preservation, Dental Implants
Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation…
- Trial name
- NCT03215667
- Testing
- easy-graft CLASSIC (beta-Tricalcium Phosphate)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sunstar Americas
Grafting, Bone
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as…
- Trial name
- NCT00206791
- Testing
- MBCP-Gel (tm), MBCP Gel
- Where
- 4 sites in France
- Volunteers
- 3 people
- Sponsor
- Biomatlante
Insufficiency Fractures, Stress Fracture
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical…
- Conditions
- Insufficiency Fractures, Stress Fracture, Stress Fracture, Ankle, Foot and Toes
- Trial name
- NCT03087396
- Testing
- Treatment of insufficiency fractures
- Where
- 12 sites in United States, Canada
- Volunteers
- 148 people
- Sponsor
- Zimmer Biomet
Subchondral Cysts, Subchondral Bone Edema
SCP Hip Outcomes Study
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting.
- Conditions
- Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures
- Trial name
- NCT03494660
- Testing
- Subchondroplasty Procedure with AccuFill
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Herniated Disc
Bone Graft Materials Observational Registry
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis
- Trial name
- APPROACH-001 (NCT00974623)
- Testing
- Bone graft substitute, autograft or allograft
- Where
- 14 sites in United States, Hungary and 1 more
- Volunteers
- 329 people
- Sponsor
- Baxter Healthcare Corporation
Bone Marrow Edema, Knee Pain Chronic
Subchondroplasty® Knee RCT
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
- Conditions
- Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee
- Trial name
- PRESERVE Knee (NCT03112200)
- Testing
- Subchondroplasty with Arthroscopy, Arthroscopy Alone
- Where
- 13 sites in United States, Canada
- Volunteers
- 131 people
- Sponsor
- Zimmer Biomet
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Periodontology, Oral Surgery
Case Series of New Alloplastic Bone Graft Material
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.
- Trial name
- NCT02221557
- Testing
- easy-graft (beta-Tricalcium Phosphate)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Sunstar Americas
Bone Substitutes
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site.
- Trial name
- GreenBric (NCT03836404)
- Testing
- Iliac crest reconstruction surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- GreenBone Ortho S.p.A.
Bone Augmentation
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications.
- Trial name
- NeoDent01 (NCT07179497)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement®
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications.
- Trial name
- Neocement01 (NCT06973226)
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.
- Trial name
- APPRAISET1 (NCT01013389)
- Testing
- Actifuse ABX, INFUSE, plus master granules (MGG)
- Where
- 2 sites in Australia, Netherlands
- Volunteers
- 20 people
- Sponsor
- Baxter Healthcare Corporation
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
Bone Augmentation
Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications.
- Trial name
- NeoInjDent01 (NCT07179510)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Peri-implantitis
Treatment of Peri-implantitis Lesions by Using Biomaterial
The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.
- Trial name
- NCT02375750
- Testing
- GBO and GBG, Standard treatment
- Where
- Sweden
- Volunteers
- 71 people
- Sponsor
- Geistlich Pharma AG
Alveolar Ridge Preservation
Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement
The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that…
- Trial name
- NCT03374813
- Testing
- MimetikOss (bone grafting surgery), Bio-Oss (bone grafting surgery)
- Where
- 8 sites in Chile, Spain
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Mimetis Biomaterials S.L.
Bone Augmentation
Evaluation of the Safety and Performance of the TriOSS®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® when used according to its intended purpose and current clinical applications.
- Trial name
- TriOSSD01 (NCT06813885)
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Non Union Fracture, Non-Union of Ankle Joint Without Infection
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
The study is aimed to compare the effectiveness of "Histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone and pure shredded…
- Trial name
- NCT04705857
- Testing
- "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- Histograft Co., Ltd.