ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
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|ClinicalTrials.gov Identifier: NCT03153449|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : March 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Knee Arthroplasty||Device: ATTUNE Revision Knee System in Total Knee Arthroplasty||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty|
|Actual Study Start Date :||September 19, 2017|
|Estimated Primary Completion Date :||March 31, 2026|
|Estimated Study Completion Date :||June 30, 2028|
ATTUNE Revision knee system
The ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
Device: ATTUNE Revision Knee System in Total Knee Arthroplasty
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty
Other Name: complex primary knee arthroplasty
- KOOS ADL [ Time Frame: 2 Years ]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.
- Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL) [ Time Frame: Baseline, 5 Year ]Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).
- Patient's Knee Implant Performance (PKIP) [ Time Frame: Baseline, 5 Year ]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
- American Knee Society Score [ Time Frame: Baseline, 5 Year ]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
- EQ-5D-5L [ Time Frame: Baseline, 5 year ]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
- VAS Pain Score [ Time Frame: Baseline, 5 year ]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).
- American Knee Society Score [ Time Frame: Baseline, 5 year ]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.
- American Knee Society Score (surgeon evaluation) [ Time Frame: Baseline, 5 year ]Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)
- Adverse Events [ Time Frame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]Evaluate type and frequency of Adverse Events
- Readmissions [ Time Frame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
- Survivorship [ Time Frame: 1, 2, 3, 4 and 5 years ]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.
- Frequency of radiolucent line occurrence [ Time Frame: 1, 2 and 5 years ]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.
- Anatomic Tibiofemoral Alignment [ Time Frame: 1, 2 and 5 years ]Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
- Femoral component alignment [ Time Frame: 1, 2 and 5 years ]Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
- Tibial component alignment [ Time Frame: 1, 2 and 5 years ]Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
- Restoration of joint line [ Time Frame: First post-operative radiograph (1 day) ]Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153449
|Contact: Thomas G. Baboolal, PhD||+44 7880 firstname.lastname@example.org|
|Contact: Susan J Kemp, PhD||+44 113 3877804 ext email@example.com|
|Study Director:||Thomas G. Baboolal, PhD||Sponsor GmbH|