Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment attune primary total knee arthroplasty
Sponsor DePuy Orthopaedics
Start date November 2012
End date March 2017
Trial size 1138 participants
Trial identifier NCT01746524, 10004

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).

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 total knee configurations: Cruciate Retaining Fixed Bearing (CR FB) Posterior Stabilized Fixed Bearing (PS FB) Cruciate Retaining Rotating Platform (CR RP) Posterior Stabilized Rotating Platform (PS RP)
attune primary total knee arthroplasty
Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
Patient Reported Outcome: Oxford Knee Score (OKS)
time frame: 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)
time frame: 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)
time frame: 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)
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
time frame: < 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
time frame: 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
time frame: 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
time frame: < 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
time frame: Operatively (Day 0 - Date of Surgery)
Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
time frame: 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
time frame: < 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
time frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

Eligibility Criteria

Male or female participants from 22 years up to 80 years old.

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.

Additional Information

Official title Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by DePuy Orthopaedics.