Clinical trial NCT01754363: Survivorship of Attune Primary Total Knee Prosthesis
Official title: Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Noninflammatory Degenerative Joint Disease
Keywords: Osteoarthritis
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 1542
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

Detailed description: Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

This study allowed for enrolment into the study by two methods. The first method was by enroling subjects to receive the implant under study with the expectation to follow them out to 15 years. The second method was done to offset follow-up attrition. The second method allowed additional interested sites that had previously participated in a two-year follow-up study (NCT01746524) on this implant (subjects implanted and followed for two years) to reconsent interested subjects to be further followed out to 15 years in this study. The original 29 sites enroled 1232 subjects. Adding of the interested sites from the 2-yr follow-up study (NCT01746524) increased the sites from 29 to 37 sites. As of the last study update, the current enrolment is now1538.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
* Subject is currently not bedridden.
* Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
* Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
* The devices specified in this protocol were implanted.

Exclusion Criteria:

* Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study.
* Subject had a contralateral amputation.
* Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently experiencing radicular pain from the spine.
* Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
* Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
* Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
* Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.).
* Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
* Subject has a medical condition with less than 5 years of life expectancy.

Primary outcomes:
measure: Survivorship of each configuration.
timeFrame: Minimum 15 years (5414 - 5658 days)
Secondary outcomes:
measure: Survivorship
timeFrame: Minimum 5 years (1764 - 3588 days)
measure: Survivorship
timeFrame: Minimum 10 years (3589 - 5413 days)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 1 year (304 - 668 days)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 2 years (669 - 1763 days)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 5 years (1764 - 3588 days)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 10 years (3589 - 5413 days)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 15 years (5414 - 5658 days)
measure: Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Patient-reported Outcome: Oxford Knee Score
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Patient-reported Outcome: Knee Society Score
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Evaluate the impact of surgeon learning curve on clinical and functional outcomes
timeFrame: <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Evaluate changes in femoral component and tibial component alignment
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
measure: Type and Frequency of Adverse Events (AEs) for all enrolled subjects
timeFrame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Fort Collins
country: United States
facility: Orthopaedic Center of the Rockies
state: Colorado
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: Mooresville
country: United States
facility: Center for Hip and Knee Surgery
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: Orthopedic One
state: Ohio
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Bone & Joint Institute
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Orthopaedic Specialists, PC
state: Pennsylvania
city: Austin
country: United States
facility: Texas Institute for Hip and Knee Surgery, LLC
state: Texas
city: Adelaide
country: Australia
facility: Canberra Hospital-Trauma & Orthopaedic Research Unit
state: South Australia
city: Vienna
country: Austria
facility: Univ.-Klinik für Orthopädie
state: Lower Austria
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen
state: Upper Austria
city: Antwerp
country: Belgium
facility: Monica Camputs O.L.V. Middelares
city: London
country: Canada
facility: University of Western Ontario-Department of Orthopaedic Surgery
state: Ontario
city: Bad Abbach
country: Germany
facility: Orthopädische Klinik für die Universität Regensburg
state: Bavaria
city: Heidelberg
country: Germany
facility: UniversitatsKlinikum Heidelberg
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
state: Dongjak-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Auckland
country: New Zealand
facility: Ascot Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital-Dept of Orthopaedic Surgery
city: Zurich
country: Switzerland
facility: Schulthess Klinik
city: Dunfermline
country: United Kingdom
facility: Queen Mary Hospital
state: Fife
city: Gobowen
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
state: Oswestry
city: Edinburgh
country: United Kingdom
facility: New Royal Infirmary of Edinburgh
state: Scotland
city: Harlow
country: United Kingdom
facility: Princess Alexandria Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: York
country: United Kingdom
facility: Clifton Park NHS Treatment Centre
Study officials:
affiliation: DePuy Synthes
name: Allyson Morris
role: STUDY_DIRECTOR
References: