ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
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|ClinicalTrials.gov Identifier: NCT03153475|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : March 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Revision Total Knee Arthroplasty||Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty||Not Applicable|
The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.
The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.
Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.
|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 Revision Total Knee Arthroplasty|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||March 31, 2029|
|Estimated Study Completion Date :||March 31, 2029|
ATTUNE Revision Knee System
The ATTUNE Revision 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 revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.
Other Name: previous unsuccessful knee replacement, knee revision
- Survivorship [ Time Frame: 5 Years ]To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.
- Patient's Knee Implant Performance (PKIP) [ Time Frame: Baseline, 2 and 5 yr timepoints ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)
- Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS) [ Time Frame: Baseline, 2 year and 5 Year ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures
- American Knee Society Score [ Time Frame: Baseline, 2 year, 5 year ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
- EQ-5D-5L [ Time Frame: Baseline, 2 year and 5 year ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures
- VAS Pain Score [ Time Frame: Baseline, 2 year and 5 year ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
- Patient Satisfaction [ Time Frame: Baseline, 2 year and 5 year ]Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
- Adverse Events [ Time Frame: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs. ]Evaluate type and frequency of Adverse Events
- Readmissions [ Time Frame: 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs ]Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
- Survivorship [ Time Frame: 1, 2, 3 and 4 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, and 4 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): NCT03153475
|Contact: Thomas G. Baboolal, PhD||+44 7880 email@example.com|
|Contact: Susan J. Kemp, PhD||+44 113 3877804 ext firstname.lastname@example.org|
|Study Director:||Thomas G. Baboolal, PhD||Sponsor GmbH|