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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 from different manufacturers will be pooled to establish a contemporary dataset.
The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.
The study is designed as a prospective, single arm stratified, multi-center investigation.
Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS).
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 a Cruciate Retaining Fixed Bearing implant configuration |
| |
| PS FB | Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration |
| |
| CR RP | Subjects receiving a Cruciate Retaining Rotating Platform implant configuration |
| |
| PS RP | Subjects receiving a Posterior Stabilized Rotating Platform implant configuration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Device | Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score | The primary endpoint will be measuerd before surgery and out to a minimum of 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. | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the psychometric properties of PKIP | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female Subjects with Non-inflammatory Degenerative Joint Disease (NIDJD) who require primary TKA with one of several designated knee systems currently on the market and are aged 22 to 80 years, inclusive.
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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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|
| 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 longitudinal functional performance of primary TKA | < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) |
| Evaluate Incidence of Anterior Knee 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 incidence of asymptomatic and symptomatic crepitus | 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 patients functional performance for PS knees, CR knees, FB knees, and RP knees | < 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 |
| Orthopaedic Center of the Rockies | Fort Collins | Colorado | 80525 | United States |
| Heekin Institute for Orthopedic Research | Jacksonville | Florida | 32205 | United States |
| The Arthroplasty Foundation | Louisville | Kentucky | 40215 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Hip and Knee Research of Nevada | Las Vegas | Nevada | 89128 | United States |
| Dartmouth Medical School/Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cardinal Orthopaedic Institute | Columbus | Ohio | 43213 | United States |
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22307-9804 | United States |
| Swedish Orthopedic Institute | Seattle | Washington | 98122-5330 | United States |
| Hornsby Ku-ring-gai Hospital | Hornsby | New South Wales | 2077 | Australia |
| Wakefield Orthopedic Clinic | Adelaide | South Australia | 5000 | Australia |
| Freemantle Hospital | Crawley | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | 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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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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