Clinical trial NCT01746524: Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
Official title: Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Arthroplasty
Replacement
Knee
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 1138
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female Subjects, age 22-80 years, inclusive, with Non-inflammatory Degenerative Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.

Brief summary: This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).

Detailed description: The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study is expected to enroll approximately 52 subjects (approximately 52 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 will be no control group. One thousand and forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating platform (CR RP), 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.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female and between the ages of 22 and 80 years, inclusive.
* Subject was diagnosed with NIDJD.
* Subject is a suitable candidate for cemented primary TKA using the devices described in the Clinical Investigation Plan (CIP)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 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 CIP.
* The devices specified in this CIP were implanted.

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 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 erythematosus, etc.).
* Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
* Subject has a medical condition with less than 2 years of life expectancy.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
timeFrame: One year or later (approximately 304 days or later)
Secondary outcomes:
measure: Patient Reported Outcome: Oxford Knee Score (OKS)
timeFrame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 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 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
timeFrame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Type and Frequency of Adverse Events (AEs) for all enrolled subjects
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate primary cemented fixation through zonal radiographic analysis post-operatively
timeFrame: minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus
timeFrame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate surgeon learning curve on clinical and functional outcomes
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate the impact of ligament balancing surgical technique on functional performance
timeFrame: Operatively (Day 0 - Date of Surgery)
measure: Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
timeFrame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate the functional outcome of patella resurfacing and non-resurfacing
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate changes in femoral component and tibial component alignment
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Fort Collins
country: United States
facility: Orhopaedic Center of the Rockies
state: Colorado
city: Louisville
country: United States
facility: The Arthroplasty Foundation
state: Kentucky
city: Las Vegas
country: United States
facility: Hip and Knee Research of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Columbus
country: United States
facility: Cardinal Orthopaedic Institute
state: Ohio
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Orthopedic Institute
state: Washington
city: Caringbah
country: Australia
facility: Sutherland Hospital
state: New South Wales
city: Hornsby
country: Australia
facility: Hornsby Ku-ring-gai Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Wakefield Orthopaedic Clinic
state: South Australia
city: Crawley
country: Australia
facility: Freemantle Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Ascot Hospital
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: Fife
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital
state: Surrey
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Llandough
country: United Kingdom
facility: University Hospital Llandough
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: York
country: United Kingdom
facility: Clifton Park NHS Treatment Centre
Study officials:
affiliation: DePuy Orthopaedics
name: Ahmad S, Ismail, MS, CCRP
role: STUDY_DIRECTOR
References:
citation: Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136.