Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- DePuy Orthopaedics
- Enrollment
- 1,138
- Locations
- 20
- Primary Endpoint
- Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
Time Frame: One year or later (approximately 304 days or later)
The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement.
Secondary Outcomes
- Type and Frequency of Adverse Events (AEs) for all enrolled subjects(< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days))
- Evaluate primary cemented fixation through zonal radiographic analysis post-operatively(minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days))
- Patient Reported Outcome: Oxford Knee Score (OKS)(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))
- Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)(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))
- Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)(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))
- Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus(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))
- Evaluate surgeon learning curve on clinical and functional outcomes(< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days))
- Evaluate the impact of ligament balancing surgical technique on functional performance(Operatively (Day 0 - Date of Surgery))
- Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire(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))
- Evaluate the functional outcome of patella resurfacing and non-resurfacing(< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days))
- Evaluate changes in femoral component and tibial component alignment(< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days))