Clinical trials: Bone Substitutes
Vasomotor Symptoms (VMS)
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
- Trial name
- NCT04080297
- Testing
- oral capsule of Q-122
- Volunteers
- 21 people
- Sponsor
- Que Oncology
Bone Diseases, Bone Cysts
Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction
This study aims to evaluate the safety and efficacy of a novel bone substitute material for the treatment of bone defects in patients requiring defect filling following the excision of benign bone tumors, cysts, or similar…
- Conditions
- Bone Diseases, Bone Cysts, Bone Neoplasm, Enchondromatosis
- Trial name
- NCT07379008
- Testing
- Non-setting paste
- Where
- Poland
- Volunteers
- 29 people
- Sponsor
- Biovico Sp. z o.o.
Deficiency of Alveolar Ridge (Disorder), Alveolar Bone Grafting
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up
long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extraction.
- Conditions
- Deficiency of Alveolar Ridge (Disorder), Alveolar Bone Grafting, Mandibular Prosthesis User
- Trial name
- NCT04868825
- Testing
- Ivory Dentin Graft, OsteoBiol Gen-Os
- Where
- Israel
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Ivory Graft 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
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
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.
Jaw, Edentulous, Jaw, Edentulous, Partially
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
- Trial name
- NCT00901017
- Testing
- Straumann BoneCeramic, Bio-Oss
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- Institut Straumann AG
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.
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
Bone Marrow Edema
SCP® Observational Study of the Knee
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 (SCP) Procedure in the knee in a standard clinical setting.
- Trial name
- NCT03110224
- Testing
- Subchondroplasty Procedure with AccuFill
- Where
- 14 sites in United States
- Volunteers
- 516 people
- Sponsor
- Zimmer Biomet
Bone Cysts, Bone Atrophy
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone…
- Conditions
- Bone Cysts, Bone Atrophy, Bone Deformity, Bone Fracture
- Trial name
- NCT03076138
- Testing
- Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- Histograft Co., Ltd.
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.
Bone Disease, Fracture Bone
Calcium Phosphate Cement Registry (CPC Registry)
CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults.
- Conditions
- Bone Disease, Fracture Bone, Bone Cyst
- Trial name
- CPC (NCT02575352)
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 500 people
- Sponsor
- Graftys SA
Turner Syndrome, Short Stature Homeobox Gene Mutation
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates.
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Trial name
- NCT07221851
- Testing
- Lonapegsomatropin [SKYTROFA®], Somatropin Pen Injector
- Where
- 51 sites in United States, France and 5 more
- Volunteers
- 186 people
- Sponsor
- Ascendis Pharma A/S
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
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
- Trial name
- APPRAISET2 (NCT01018771)
- Testing
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Baxter Healthcare Corporation
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
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.
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