Joint Research Studies
Involved Physicians
Insignia
Active but not enrolling patients
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Official Study Title
Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery
Description
This is a 10 year-long, post-market study assessing the Insignia™ Hip Stem for total hip replacements. The Insignia™ Hip Stem features a short stem design with a plasma-sprayed Hydroxyapatite coating, which has been shown to achieve long-lasting bony fixation and stability.
Additional information can be found at:
Or3o Total Hip Arthroplasty
Active & enrolling patients
Official Study Title
Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures.
Description
This is a 10 year-long, post-market study designed to assess the hip replacement implant known as the OR3O™ Dual Mobility System. The implant is unique in its design in that it has two points of movement making it a dual mobility system.
Additional information can be found at:
Oxinium DH Total Hip Arthroplasty
Active but not enrolling patients
Official Study Title
A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM™ DH Total Hip Replacement System in Subjects with Non-Inflammatory Arthritis
Description
This is a 10 year-long study, Phase 3 study designed to assess the OXINIUM™ DH Hip System for FDA approval. The OXINIUM™ DH Hip System is composed of a ceramicized metal that is believed to be able to resist wear and breaking of the hip replacement better than other devices on the market.
R3 Total Hip Arthroplasty
Active but not enrolling patients
Official Study Title
Post-Approval Study of the R3™ Biolox® Delta Ceramic Acetabular System—United States
Description
This is a 3-year-long, post-market study collecting information about how the R3™ Biolox® Delta Ceramic Acetabular System performs in patients in the United States.
Additional information can be found at:
LEGION Total Knee Arthroplasty
Active but not enrolling patients
Official Study Title
Safety and Performance of Primary Total Knee Arthroplasty using Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Description
This is a 10 year-long, post-market study designed to assess the safety and effectiveness of the Legion™ CR Oxinium and CoCr Femoral Implants combined with LEGION™/Genesis™ II XLPE High Flex Tibial Inserts in knee replacements.
Additional information can be found at:
JIIXR Total Knee Arthroplasty
Active but not enrolling patients
Official Study Title
A Prospective, Multicenter, Post-Market Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Journey™ II XR Total Knee System
Description
This is a 10 year-long, post-market study collecting safety and performance data from long-term use of the JOURNEY™ II XR Total Knee System. The device is designed to retain both the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) leaving the knee with more functional integrity.
Additional information can be found at:
Retrospective JIICR Total Knee Arthroplasty
Complete
Official Study Title
Safety and Performance of Journey™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
Description
The purpose of this study is to evaluate the safety and performance of the Journey II CR Total Knee System. The device retains the posterior cruciate ligament (PCL) and is designed to combine the satisfaction of a partial knee replacement with the long-term survivorship of a total knee replacement.
Zilretta/Celestone Knee OA
Completed
Official Study Title
Effect of ZILRETTA versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance.
Description
This is a 12-week study designed to assess the effect of ZILRETTA versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance on patients with knee osteoarthritis.
Retrospective JIIXR Total Knee Arthroplasty
Completed
Official Study Title
Safety and Performance of the Journey II XR Total Knee System. A Retrospective, Multicenter Study
Description
This study investigated the safety and performance of the Journey II XR Total Knee System. The device used in this study retains the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL), which maintains functional integrity of the knee.
Wellframe Mobile App Validation
Completed
Official Study Title
Patient Reported Outcome Measurement Information System (PROMIS) Computer Adaptive Test (CAT) domains—Validation and Comparison with the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) in Total Knee Arthroplasty
Description
The purpose of this study was to collect data on patients’ mental, physical, and social health before and after having a total knee replacement. Participants downloaded an app called Wellframe, which would prompt users to complete surveys regarding their current condition. This information was used to ensure proper functionality and determine possible areas of improvement.
Wellframe Mobile App Feasability
Completed
Official Study Title
Feasibility Study in the Collection of Electronic Patient Reported Outcome Measurements (PROMIS) in Total Knee Arthroplasty Subjects using Wellframe App
Description
The purpose of this study was to collect data on the feasibility of using an app called Wellframe to measure patient outcomes before and after having a total knee replacement. The study examined if individuals could use the app effectively and if they answered all surveys prompted by the app.
J2 Flouro Study
Completed
Official Study Title
Multi-center In vivo kinematics for subjects implanted with Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Description
This study determined and compared the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), Cruciate Retaining (CR), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee System was designed to resect and replicate both the posterior and anterior cruciate ligaments, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so that they remain intact.
If you have further questions regarding research, please contact rocresearch@renoortho.com