Osteoarthritis Clinical Trial
Official title:
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device. 157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator. The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative. The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively. Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed. ;
| 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| Withdrawn |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 |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
| Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
| Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
| Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
| Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A |