Clinical trial NCT03153449: ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Official title: Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Knee Arthroplasty
Keywords: complex primary, deformity, ligamentous laxity
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 complex primary total knee arthroplasty.

Detailed description: 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: Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. The decision to have knee replacement with the study device is regardless of the research.
3. The devices are to be used according to the approved indications.
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. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
7. 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.
8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
3. Subject had a contralateral amputation.
4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
8. 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.
9. 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.
10. 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).
11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

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Primary outcomes:
measure: KOOS ADL
timeFrame: 2 Years
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)
timeFrame: Baseline, 5 Year
measure: Patient's Knee Implant Performance (PKIP)
timeFrame: Baseline, 5 Year
measure: American Knee Society Score
timeFrame: Baseline, 5 Year
measure: EQ-5D-5L
timeFrame: Baseline, 5 year
measure: VAS Pain Score
timeFrame: Baseline, 5 year
measure: American Knee Society Score
timeFrame: Baseline, 5 year
measure: American Knee Society Score (surgeon evaluation)
timeFrame: Baseline, 5 year
measure: Adverse Events
timeFrame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
measure: Readmissions
timeFrame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
measure: Survivorship
timeFrame: 1, 2, 3, 4 and 5 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: Adelaide
country: Australia
facility: Finders Private Hospital
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: 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: Verona
country: Italy
facility: Ospedale Sacro Cuore
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: Middlesbrough
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: Grant Jamgochian
role: STUDY_DIRECTOR
References: