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ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.
Study details:
Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint. This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA.
The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations. The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes.
Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc. , necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 22 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-09-19
Primary completion: 2026-03-31
Study completion finish: 2028-06-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT03153449
Intervention or treatment
DEVICE: ATTUNE Revision Knee System in Total Knee Arthroplasty
Conditions
- • Primary Knee Arthroplasty
Find a site
Closest Location:
Finders Private Hospital
Research sites nearby
Select from list below to view details:
Finders Private Hospital
Adelaide, Not Specified, Australia
St. John of God Murdoch Hospital
Perth, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: ATTUNE Revision knee system
| DEVICE: ATTUNE Revision Knee System in Total Knee Arthroplasty
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| KOOS ADL | Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations. | 2 Years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL) | Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM). | Baseline, 5 Year |
| Patient's Knee Implant Performance (PKIP) | Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure | Baseline, 5 Year |
| American Knee Society Score | valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure | Baseline, 5 Year |
| EQ-5D-5L | Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure | Baseline, 5 year |
| VAS Pain Score | Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale). | Baseline, 5 year |
| American Knee Society Score | Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale. | Baseline, 5 year |
| American Knee Society Score (surgeon evaluation) | Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation) | Baseline, 5 year |
| Adverse Events | Evaluate type and frequency of Adverse Events | Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. |
| Readmissions | Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic). | 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. |
| Survivorship | Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, 4 and 5 years. | 1, 2, 3, 4 and 5 years |
| Frequency of radiolucent line occurrence | Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs. | 1, 2 and 5 years |
| Anatomic Tibiofemoral Alignment | Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years |
| Femoral component alignment | Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years |
| Tibial component alignment | Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs. | 1, 2 and 5 years |
| Restoration of joint line | Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie. | First post-operative radiograph (1 day) |
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