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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 Attuneâ„¢ 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 (Attuneâ„¢ CR FB), cruciate retaining rotating platform (Attuneâ„¢ CR RP), posterior stabilized fixed bearing (Attuneâ„¢ PS FB), and posterior stabilized rotating platform (Attuneâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR FB | Subjects receiving Cruciate Retaining Fixed Bearing configuration of ATTUNE Primary Knee Implant |
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| PS FB | Subjects receiving Posterior Stabilized Fixed Bearing configuration of ATTUNE Primary Knee Implant |
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| CR RP | Subjects receiving Cruciate Retaining Rotating Platform configuration of ATTUNE Primary Knee Implant |
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| PS RP | Subjects receiving Posterior Stabilized Rotating Platform configuration of ATTUNE Primary Knee Implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTUNE Primary Total Knee Arthroplasty | Device | Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP). |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline. | The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement. | One year or later (approximately 304 days or later) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome: Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having 5 Likert- like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female Subjects, age 22-80 years, inclusive, with Non-inflammatory Degenerative Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad S, Ismail, MS, CCRP | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialty Institute | Orange | California | 92868 | United States | ||
| UCSD Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34908561 | Derived | Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136. |
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| Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) | The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Type and Frequency of Adverse Events (AEs) for all enrolled subjects | All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor. | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate primary cemented fixation through zonal radiographic analysis post-operatively | Radiographs will be reviewed by an independent radiographic reviewer (IRR). Data from the IRR radiographic evaluations will be used for determination of radiographic success criteria. | minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus | The Anterior Knee Pain and Crepitus questionnaire will be used. It is a 2 part questionnaire that is patient-self administered. The crepitus questions include frequency of crepitus and whether or not crepitus is symptomatic. The anterior knee pain contains 2 questions that collect frequency of pain and location of pain. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate surgeon learning curve on clinical and functional outcomes | Each surgeon will implant devices into the first 10 Subjects which will be considered as 'learning curve cases'; these learning curve cases will not be pooled with post-learning curve cases unless learning curve analyses indicate that there is not a significant learning curve with regard to clinical or functional Subject outcomes. | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate the impact of ligament balancing surgical technique on functional performance | Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated. | Operatively (Day 0 - Date of Surgery) |
| Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire | The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option. | Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate the functional outcome of patella resurfacing and non-resurfacing | An exploratory comparison of results between knees with patella resurfacing versus knees without resurfacing will be conducted. A comparison of KOOS, PKIP, OKS, Knee Society (AKS), anterior knee pain incidence, and crepitus will be conducted. | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate changes in femoral component and tibial component alignment | Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time. | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| San Diego |
| California |
| 92103 |
| United States |
| Orhopaedic Center of the Rockies | Fort Collins | Colorado | 80525 | United States |
| The Arthroplasty Foundation | Louisville | Kentucky | 40215 | United States |
| Hip and Knee Research of Nevada | Las Vegas | Nevada | 89128 | United States |
| Dartmouth Medical School/Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03765 | United States |
| Cardinal Orthopaedic Institute | Columbus | Ohio | 43213 | United States |
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22307 | United States |
| Swedish Orthopedic Institute | Seattle | Washington | 98122 | United States |
| Sutherland Hospital | Caringbah | New South Wales | 2229 | Australia |
| Hornsby Ku-ring-gai Hospital | Hornsby | New South Wales | 2077 | Australia |
| Wakefield Orthopaedic Clinic | Adelaide | South Australia | 5000 | Australia |
| Freemantle Hospital | Crawley | Western Australia | 6009 | Australia |
| Ascot Hospital | Auckland | New Zealand |
| Queen Margaret Hospital | Dunfermline | Fife | KY12 OSU | United Kingdom |
| The Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| Princess Alexandra Hospital | Harlow | CM20 1QX | United Kingdom |
| University Hospital Llandough | Llandough | CF64 2XX | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Clifton Park NHS Treatment Centre | York | YO30 5RA | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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