Overview

This trial is active, not recruiting.

Condition noninflammatory degenerative joint disease
Treatment attune primary total knee replacement
Sponsor DePuy International
Start date February 2013
End date February 2030
Trial size 1200 participants
Trial identifier NCT01754363, 10008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
attune primary total knee replacement
Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).

Primary Outcomes

Measure
Survivorship of each configuration.
time frame: Minimum 15 years (5414 - 5658 days)

Secondary Outcomes

Measure
Survivorship
time frame: Minimum 5 years (1764 - 3588 days)
Survivorship
time frame: Minimum 10 years (3589 - 5413 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
time frame: Minimum 1 year (304 - 668 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
time frame: Minimum 2 years (669 - 1763 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
time frame: Minimum 5 years (1764 - 3588 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
time frame: Minimum 10 years (3589 - 5413 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
time frame: Minimum 15 years (5414 - 5658 days)
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
time frame: 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).
Patient-reported Outcome: Oxford Knee Score
time frame: 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).
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 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).
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
time frame: 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).
Patient-reported Outcome: Knee Society Score
time frame: 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).
Evaluate the impact of surgeon learning curve on clinical and functional outcomes
time frame: <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).
Evaluate changes in femoral component and tibial component alignment
time frame: 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).
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
time frame: 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).

Eligibility Criteria

Male or female participants from 22 years up to 75 years old.

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.

Additional Information

Official title Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
Description This study is designed as a prospective, single arm stratified, multi-centre investigation. 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by DePuy International.