Clinical trials: Revision
Arthropathy, Hip Arthropathy
Restoration Anatomic Acetabular Shell Revision Study
This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively.
- Conditions
- Arthropathy, Hip Arthropathy, Hip Osteoarthritis
- Trial name
- RAS (NCT05591859)
- Testing
- Restoration Anatomic Acetabular Shell
- Where
- United States
- Sponsor
- Stryker Orthopaedics
Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
- Conditions
- Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions
- Trial name
- NCT01828801
- Testing
- Pinnacle Metal-on Metal
- Where
- 8 sites in United States
- Volunteers
- 276 people
- Sponsor
- DePuy Orthopaedics
Presbyopia
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.
- Trial name
- NCT03017612
- Testing
- Raindrop Near Vision Inlay
- Where
- 6 sites in United States
- Volunteers
- 13 people
- Sponsor
- ReVision Optics, Inc.
Osteoarthritis
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years…
- Trial name
- NCT02912351
- Testing
- Patient record review, Radiographs, and questionaires.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Total Knee Arthroplasty
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed.
- Trial name
- NCT06578897
- Testing
- 3D Metal Tibial and Femoral cones
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Medacta International SA
Thoracic Insufficiency Syndrome
A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System
The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.
- Trial name
- NCT01716936
- Where
- 15 sites in Egypt, Finland and 5 more
- Volunteers
- 54 people
- Sponsor
- Ellipse Technologies, Inc.
Weight Loss
Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey 1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli® (orlistat 60 mg) were recommended.
- Trial name
- NCT02141230
- Testing
- Alli® 60 mg
- Sponsor
- GlaxoSmithKline
Arthroplasties, Hip Replacement
REDAPT Retrospective-Prospective Modular Stem Study
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market…
- Trial name
- NCT02661620
- Testing
- REDAPT Revision Femoral System modular stem
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Leber Hereditary Optic Disease
Efficacy and Safety Study of Bilateral IVT Injection of GS010 at Two Dose Levels in LHON Patients
The goal of this Clinical trial is to assess the safety and efficacy of GS010 at two dose levels on visual acuity and retinal mitochondrial activity in patients affected with ND4 Leber Hereditary Optic Neuropathy (LHON)
- Trial name
- REVISE (NCT07303296)
- Testing
- GS010 High dose, GS010 Low dose
- Where
- France
- Volunteers
- 14 people
- Sponsor
- GenSight Biologics
Keloid
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing…
- Trial name
- NCT01446770
- Testing
- Hydrogel scaffold (MF-4181)
- Where
- The Bahamas
- Volunteers
- 19 people
- Sponsor
- Halscion, Inc.
Survival, Prosthesis
Prevision® PMCF Study
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results…
- Trial name
- NCT03510065
- Testing
- Prevision®
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Total Knee Replacement Revision
LEGION™ Revision Metal Hypersensitivity Study
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
- Trial name
- NCT02412813
- Testing
- LEGION OXINIUM, LEGION Cobalt Chrome
- Where
- 3 sites in United States, Canada
- Sponsor
- Smith & Nephew, Inc.
Joint Disease
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Single center, prospective follow-up of previously implanted subjects
- Trial name
- NCT04064008
- Testing
- PROFEMUR® Z Revision Femoral Stem
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- MicroPort Orthopedics Inc.
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Breast Reconstruction
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
- Trial name
- NCT00691327
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 84,329 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
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
Breast Augmentation
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
- Trial name
- MIRO (NCT05449587)
- Testing
- MRI and PRO
- Where
- 2 sites in Costa Rica
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Arthroplasties, Knee Replacement, Revision Arthroplasty
Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow…
- Trial name
- NCT06203756
- Testing
- Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
- Where
- 6 sites in United States
- Volunteers
- 713 people
- Sponsor
- Corin
Adverse Local Tissue Reaction, Total Hip Arthroplasty
ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
- Trial name
- NCT01884532
- Testing
- ASR-XL Metal-on-Metal
- Where
- 7 sites in United States
- Volunteers
- 146 people
- Sponsor
- DePuy Orthopaedics