Osteoarthritis
Conditions
Keywords
Arthroplasty, replacement, Knee, function, radiographic, survivorship
Brief summary
The primary objective is to investigate 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) in the Japanese patient population.
Detailed description
* 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 configurations using Kaplan-Meier survival analysis at 1 and 2yrs. * Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery. * Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs. * Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
Interventions
Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP)
Sponsors
Johnson & Johnson K.K. Medical Company
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
An independent radiographic reviewer will be assessing all radiographs from the study.
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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 Japanese.
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 investig ation 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 Acc ident Insurance claims (similar to Workers Compensation in USA). * 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 question naires 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 two (2) years life expectancy. * Uncontrolled gout
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) | Minimum 2 years (670-912 days after surgery) | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) | Minimum 2 years (670-912 days after surgery) | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. 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. |
| Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011 | Minimum 2 years (670-912 days after surgery) | The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options. |
| Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) | Minimum 2 years (670-912 days after surgery) | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. |
| Modified VAS Pain Score: Pain and Satisfaction | Minimum 2 years (670-912 days after surgery) | VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale |
| Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) | Minimum 2 years (670-912 days after surgery) | The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option. |
| Survivorship | Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) | Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP) |
| Implant fixation: Radiographic assessment of bone-implant interface performance | 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change \>3degrees in any plane. |
| Evaluate changes in femoral component and tibial component alignment | Minimum 2 years (670-912 days after surgery) | Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change \>3degrees in any plane. |
| Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population. | Minimum 1 year (304-669 days after surgery) | Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove. |
| Type and Frequency of Adverse Events (AEs) for all enrolled subjects | Pre-op (-180 to -1 days before surgery), 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) | All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor. |
Countries
Japan
Outcome results
None listed