Clinical trial NCT03153475: ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Official title: Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Revision Total Knee Arthroplasty
Keywords: Revision knee surgery, implant replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 revision total knee arthroplasty.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.
3. The decision to perform a knee revision with the study device is regardless of the research.
4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
5. Subject is currently not bedridden
6. The devices are to be used according to the approved indications.Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study.
3. Subject had a contralateral amputation.
4. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
5. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
6. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
7. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
8. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
9. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
10. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
11. Uncontrolled gout

Primary outcomes:
measure: Survivorship
timeFrame: 5 Years
Secondary outcomes:
measure: Patient's Knee Implant Performance (PKIP)
timeFrame: Baseline, 2 and 5 yr timepoints
measure: Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
timeFrame: Baseline, 2 year and 5 Year
measure: American Knee Society Score
timeFrame: Baseline, 2 year, 5 year
measure: EQ-5D-5L
timeFrame: Baseline, 2 year and 5 year
measure: VAS Pain Score
timeFrame: Baseline, 2 year and 5 year
measure: Patient Satisfaction
timeFrame: Baseline, 2 year and 5 year
measure: Adverse Events
timeFrame: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
measure: Readmissions
timeFrame: 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
measure: Survivorship
timeFrame: 1, 2, 3 and 4 years
measure: Frequency of radiolucent line occurrence
timeFrame: 1, 2 and 5 years
measure: Anatomic Tibiofemoral Alignment
timeFrame: 1, 2 and 5 years
measure: femoral component alignment
timeFrame: 1, 2 and 5 years
measure: Tibial component alignment
timeFrame: 1, 2 and 5 years
measure: Restoration of joint line
timeFrame: First post-operative radiograph (1 day)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Fort Collins
country: United States
facility: Orthopaedic Center of the Rockies
state: Colorado
city: Niantic
country: United States
facility: Orthopedic Partners
state: Connecticut
city: DeLand
country: United States
facility: Florida Orthopedic Associates
state: Florida
city: Louisville
country: United States
facility: Arthroplasty Foundation
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Ozark
country: United States
facility: Mery Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Orthopaedics
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Hip and Knee Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Southern Joint Replacement Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Institute for Hip & Knee Surgery
state: Texas
city: Houston
country: United States
facility: Fondren Orthopedic Group
state: Texas
city: Gold Coast
country: Australia
facility: The Gold Coast Centre for Bone and Joint Surgery
city: Perth
country: Australia
facility: St. John of God Murdoch Hospital
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
city: Antwerp
country: Belgium
facility: MoRe Foundation
city: London
country: Canada
facility: London Health Sciences Centre University Hospital
state: Ontario
city: Winnipeg
country: Canada
facility: Concordia Joint Replacement
city: Brest
country: France
facility: CHRU La Cavale Blanche
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Munich
country: Germany
facility: Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
city: Schwandorf
country: Germany
facility: Asklepios Orthopädische Klinik Lindenlohe
city: Cork
country: Ireland
facility: South Infirmary Public Hospital
city: Bergamo
country: Italy
facility: CLINICHE GAVAZZENI SPA aka Humanitas Castelli
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Basel
country: Switzerland
facility: Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital NHS Fife
city: Leeds
country: United Kingdom
facility: Chapel Allerton Orthopaedic Centre
city: North Yorkshire
country: United Kingdom
facility: James Cook University Hospital
city: Oswestry
country: United Kingdom
facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: Sponsor GmbH
name: Sukhjeet Kaur
role: STUDY_DIRECTOR
References: