Clinical trial NCT02839850: 14022 ATTUNE Cementless RP Clinical Performance Evaluation
Official title: Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Arthroplasty
replacement
Knee
function
radiographic
survivorship
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 540
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: The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

Detailed description: The secondary objectives of this study are:

* Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
* Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
* Evaluate type and frequency of Adverse Events
* Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
* Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
* Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
* 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
* Subject is currently not bedridden
* 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.
* Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations.

Exclusion Criteria:

* The 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 (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
* Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* 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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
* 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.
* Subject has a significant neurological or musculoskeletal disorder(s) 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 erythematosus, etc.).
* Subject has a medical condition with less than five (5) years life expectancy.
* Uncontrolled gout

Primary outcomes:
measure: Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
timeFrame: Minimum 2 years (670-1033 days after surgery)
Secondary outcomes:
measure: Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Modified VAS Pain Score: Pain and Satisfaction
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Type and Frequency of Adverse Events (AEs) for all enrolled subjects
timeFrame: Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
measure: Survivorship
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Survivorship
timeFrame: Minimum 5 years (1764-2190 days after surgery)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: 6 weeks (1-90 days after surgery)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: 6 months (91-303 days after surgery)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 1 year (304-669 days after surgery).
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: Minimum 2 years (670-1033 days after surgery)
measure: Evaluate changes in femoral component and tibial component alignment
timeFrame: Minimum 2 years (670-1033 days after surgery)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: DeLand
country: United States
facility: Florida Research Associates
state: Florida
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New London
country: United States
facility: New London Hospital
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY downstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Kingsport
country: United States
facility: Associated Orthopaedics of Kingsport
state: Tennessee
city: Lubbock
country: United States
facility: Texas Tech University Heath Science Center
state: Texas
city: Newport News
country: United States
facility: Hampton Roads Orthopaedics and Sports Medicine
state: Virginia
city: Ried im Innkreis
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
state: Upper Austria
city: Calgary
country: Canada
facility: Foothills Medical Centre, University of Calgary
state: Alberta
city: Brest
country: France
facility: CHU de la Cavale Blanche
state: Cedex
city: Salouel
country: France
facility: Sevice de Chirurgie Orthoedique et Traumatologique
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen GmbH
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
state: Noord-Brabant
city: Christchurch
country: New Zealand
facility: University of Otago
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Sponsor GmbH
name: Sukhjeet Kaur
role: STUDY_DIRECTOR
References: