Clinical trials: Fractures, Bone
Spinal Fractures, Fractures, Compression
The Kiva® System as a Vertebral Augmentation Treatment
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or…
- Conditions
- Spinal Fractures, Fractures, Compression, Back Injuries
- Trial name
- KAST (NCT01123512)
- Testing
- Vertebral augmentation
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Benvenue Medical, Inc.
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Osteoporosis, Osteoporosis, Age-Related
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis
- Trial name
- NCT03512262
- Testing
- Abaloparatide
- Where
- 34 sites in United States, Italy and 1 more
- Volunteers
- 228 people
- Sponsor
- Radius Health, Inc.
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Distal Radius Fractures
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05987033
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 11 people
- Sponsor
- Novadip Biosciences
Osteoporosis
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
- Trial name
- NCT00205777
- Testing
- Bazedoxifene Acetate
- Where
- 375 sites in United States, Argentina and 28 more
- Volunteers
- 7,609 people
- Sponsor
- Pfizer
Bone Metastases, Fractures, Bone
EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
- Conditions
- Bone Metastases, Fractures, Bone, Bone Tumor
- Trial name
- EPIBONE (NCT06376682)
- Testing
- CT-guided bone percutaneous procedure
- Where
- 3 sites in France
- Volunteers
- 34 people
- Sponsor
- Quantum Surgical
Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41
chronOS Inject in Proximal Tibial Fractures
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- Trial name
- NCT02056834
- Testing
- chronOS Inject
- Where
- 2 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Synthes GmbH
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck
N-Force Screws Augmented With N-Force Blue in Hip Fractures
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
- Conditions
- Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Trial name
- N-Force (NCT03807349)
- Testing
- N-Force Screws Augmented with N-Force Blue
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Zimmer Biomet
Fracture of Clavicle
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the…
- Trial name
- NCT01975467
- Testing
- CRx
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sonoma Orthopedic Products, Inc.
Pain
A Pilot Study of TRV130 for the Treatment of Fracture Pain
The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
- Trial name
- NCT02520297
- Testing
- TRV130
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Trevena Inc.
Tibial Fractures
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
- Trial name
- TRUST (NCT00667849)
- Testing
- Exogen 4000+
- Where
- 16 sites in United States, Canada
- Volunteers
- 501 people
- Sponsor
- Bioventus LLC
Male Osteoporosis
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
- Trial name
- NCT00439647
- Testing
- Zoledronic acid 5 mg iv
- Where
- 128 sites in Argentina, Australia and 21 more
- Volunteers
- 1,199 people
- Sponsor
- Novartis Pharmaceuticals
Wrist Injury, Tibial Fracture
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Trial name
- TOMO (NCT01927575)
- Testing
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Foot Deformities, Acquired, Disorder of Joint of Foot
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Trial name
- NCT02161016
- Testing
- map3
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- RTI Surgical
Vertebral Body Compression Fractures (VCFs)
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a…
- Trial name
- MDTSCORE (NCT00810043)
- Testing
- Kyphon® Curette
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Spine LLC
Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head
- Trial name
- OR3O (NCT04941729)
- Testing
- OR3O™ - Dual Mobility System, Conventional
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.