Osteoarthritis Clinical Trial
Official title:
Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
This post-marketing investigation will evaluate the functional knee performance of Subjects
who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one
of four contemporary knee configurations will be pooled to establish a contemporary dataset.
The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1
day before surgery) to minimum one year (approximately 304 to 668 days) postoperative
functional performance improvement for the Attune™ primary, cemented TKA system as measured
by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score
(KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant
configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating
platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior
stabilized rotating platform (Attune™ PS RP).
The study is designed as a prospective, single arm stratified, multi-center investigation.
Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study
is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10
subjects per site may be recruited at sites which have Sub-Investigators participating in the
study. Cohort reallocation is permitted. There will be no control group. One thousand and
forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed
bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating
platform (CR RP), and posterior stabilized rotating platform (PS RP). Treatment assignment in
this study is not randomized.
Each site will only enroll patients in one of the four knee configuration sub-groups most
commonly used as their standard of care.
;
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 |