DSJ-2016-07 ATTUNE® Cementless CR RP Japan
- Conditions
- Osteoarthritis
- Interventions
- Device: Cementless Total Knee Arthroplasty
- Registration Number
- NCT03193034
- Lead Sponsor
- DePuy Orthopaedics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ATTUNE Cementless RP TKA Cementless Total Knee Arthroplasty Subjects will receive a cementless, rotating platform total knee arthroplasty.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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.
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)
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.
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.
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.
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.
Trial Locations
- Locations (4)
Kobe University Graduate School of Medicine
🇯🇵Kobe, Hyogo, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya orthopedic Clinic
🇯🇵Kitanagoya, Aichi, Japan
Osaka Rosai Hospital
🇯🇵Sakai, Osaka, Japan