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This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).
This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees).
This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care.
Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTUNE Primary, Cemented Total Knee Replacement | Subjects will receive one of four available ATTUNE total knee implants: (CR FB, CR RP, PS FB, PS RP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTUNE Primary, Cemented Total Knee Replacement | Device | Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP). |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points. | The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best. | 6 Months Post-Operative minus Pre-Op |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS-PS change from baseline of the ATTUNE knee | The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verdonna Huey, MS, BSN, CCRP | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital - Orthopaedic Department | Arnhem | Gelderland | 6800 | Netherlands | ||
| Lievensberg Hospital Orthopaedic Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33864173 | Derived | van Loon C, Baas N, Huey V, Lesko J, Meermans G, Vergroesen D. Early outcomes and predictors of patient satisfaction after TKA: a prospective study of 200 cases with a contemporary cemented rotating platform implant design. J Exp Orthop. 2021 Apr 17;8(1):30. doi: 10.1186/s40634-021-00347-w. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Pre-Op (-90 days to day of surgery), 6 weeks (1 - 60 days), 3 months (61 - 137 days), 1 year (304 - 669 days), and 2 years (670 - 913 days) post-operative |
| Length of Hospital Stay | Collect days of hospitalization related to TKA procedure | Immediate-post-operative: average 1 week |
| Annual Survivorship | A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant. | 1 year (304 - 669 days), 2 years (670 - 913 days) post-operative |
| Type and frequency of Adverse Events (AEs) for all enrolled subjects | All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol. | Day 0 - Post-Operative Day 913 |
| Bergen op Zoom |
| North Brabant |
| 4624 |
| Netherlands |
| Spaarne Hospital Orthopaedic Department | Hoofddorp | North Holland | 2134 | Netherlands |
| HAGA Hospital Orthopaedic Department | The Hague | South Holland | 2566 | Netherlands |