Osteoarthritis Clinical Trial
Official title:
Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information
regarding the performance and safety of the commercially available Ceramax™ Ceramic on
Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase
and a clinical outcomes phase.
In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered
for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective
evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey
will be mailed to subjects annually.
This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This
study will follow each subject through 10 years postoperatively and will consist of:
1. a clinical follow-up phase and
2. a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then
annually through year 5 for each subject. For years 6 - 10, a communication will be sent to
each subject in order to collect survivorship and general health information. This
communication will ask whether the COC device is still in vivo and, if not, when the revision
surgery took place, why, and which components were removed, if applicable. In addition,
subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up
interval. A self-addressed, stamped envelope will be provided to facilitate information
return and privacy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
| Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
| Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
| Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
| Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
| Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
| Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
| Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
| Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
| Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
| Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
| Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A | |
| Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |