Clinical trials: Bone Fractures
Fracture
Anatomical Shoulder™ Fracture PMCF Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02465398
- Testing
- Fracture Shoulder Arthroplasty
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Femoral Fracture
Post Market Clinical Evaluation of Gamma 4
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
- Trial name
- PEGASUS (NCT05523635)
- Testing
- Gamma4 Nailing System
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-HIP2 (NCT00721760)
- Testing
- Enoxaparin sodium, Semuloparin sodium
- Where
- 25 sites in United States, Argentina and 23 more
- Volunteers
- 1,003 people
- Sponsor
- Sanofi
Osteoarthritis, Avascular Necrosis
PMCF Study of the CLS Brevius Stem With Kinectiv Technology
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Femoral Neck Fractures
- Trial name
- NCT03410940
- Testing
- CLS Brevius stem with Kinectiv technology
- Where
- 4 sites in Italy, Poland and 1 more
- Volunteers
- 223 people
- Sponsor
- Zimmer Biomet
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT03547947
- Testing
- Medacta Shoulder System
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
Fall, Fall Patients
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of…
- Conditions
- Fall, Fall Patients, Osteoporosis
- Trial name
- FAIR (NCT05155761)
- Testing
- FeetMe® Monitor
- Where
- France
- Volunteers
- 250 people
- Sponsor
- FeetMe
Fracture
Clinical Validation of Boneview for FDA Submission
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs.
- Trial name
- NCT04532580
- Testing
- Diagnosis of fracture on X-Ray Radiographs
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Gleamer
Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip
MDR Vivacit-E Elevated Study
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
- Conditions
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip
- Trial name
- NCT07150221
- Testing
- Vivacit-E Elevated Liners
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Hip Fracture
Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.
- Trial name
- NCT00521716
- Testing
- Intracapsular Femoral Fracture Fixation, WaisFix100i for Intracapsular Femoral Fracture Fixation
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- OrthoMediTec
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00208377
- Testing
- DePuy ASR Hip System
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 228 people
- Sponsor
- DePuy International
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System FR
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05926622
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Osteoarthritis, Rheumatoid Arthritis
A Clinical Investigation of the Discovery™ Elbow System
The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis, Humeral Fractures
- Trial name
- NCT00698867
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Biomet Orthopedics, LLC
Osteoarthritis, Avascular Necrosis
Persona Partial Knee Clinical Outcomes Study
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Conditional Tibial Condyle or Plateau Fractures
- Trial name
- NCT03034811
- Testing
- Persona Partial Knee system
- Where
- 24 sites in United States, Austria and 8 more
- Volunteers
- 757 people
- Sponsor
- Zimmer Biomet
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Fracture, Infection, Human Immunodeficiency Virus
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01077557
- Testing
- No Antiretroviral (ARV) Drug Exposure, Any Antiretroviral (ARV) Drug Exposure
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
Degenerative Disease, Oncology
Comprehensive Segmental Revision System
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
- Conditions
- Degenerative Disease, Oncology, Revision Surgery, Trauma
- Trial name
- NCT03270982
- Testing
- Comprehensive SRS Replacement
- Where
- 4 sites in Canada, Denmark and 1 more
- Volunteers
- 105 people
- Sponsor
- Zimmer Biomet
Pelvic Ring Fracture, Acetabular Fracture
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
- Conditions
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum
- Trial name
- NCT05606042
- Testing
- IM Implant
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- CurvaFix, Inc.
Radius Fractures
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture…
- Trial name
- NCT00161629
- Testing
- rhBMP-2/CPM
- Where
- 7 sites in Finland, France
- Volunteers
- 40 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer