Osteoarthritis Clinical Trial
Official title:
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population
NCT number | NCT03193034 |
Other study ID # | DSJ-2016-07 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2017 |
Est. completion date | June 30, 2021 |
Verified date | September 2021 |
Source | DePuy Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Nagoya orthopedic Clinic | Kitanagoya | Aichi |
Japan | Kobe University Graduate School of Medicine | Kobe | Hyogo |
Japan | Nagoya City University Hospital | Nagoya | Aichi |
Japan | Osaka Rosai Hospital | Sakai | Osaka |
Lead Sponsor | Collaborator |
---|---|
DePuy Orthopaedics | Johnson & Johnson K.K. Medical Company |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) | 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. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) | 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. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011 | 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. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Modified VAS Pain Score: Pain and Satisfaction | 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 | Minimum 2 years (670-912 days after surgery) | |
Secondary | Type and Frequency of Adverse Events (AEs) for all enrolled subjects | All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor. | 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) | |
Secondary | Survivorship | Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP) | Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) | |
Secondary | Implant fixation: Radiographic assessment of bone-implant interface performance | 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. | 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) | |
Secondary | Evaluate changes in femoral component and tibial component alignment | 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. | Minimum 2 years (670-912 days after surgery) | |
Secondary | Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population. | Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove. | Minimum 1 year (304-669 days after surgery) |
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