Osteoarthritis
Conditions
Interventions
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
Sponsors
Johnson & Johnson K.K. Medical Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following specific criteria will be considered for participation in the study: a) Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive. b) Subject was diagnosed with NIDJD. c) 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. d) 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. e) Subject is currently not bedridden f) 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. g) Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in Japanese.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in the study if they meet any of the following criteria: a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study c) Subject had a contralateral amputation. d) Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. e) Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. f) Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. g) Subject is currently involved in any personal injury litigation, medical-legal or Worker's Accident Insurance claims (similar to Workers Compensation in USA). h) 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 questionnaires or be compliant with follow-up requirements. i) 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. j) 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). k) Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). l) Subject has a medical condition with less than two (2) years life expectancy. m) Uncontrolled gout
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) | — |
Countries
Japan
Contacts
Public ContactMiyuki Sakamoto Miyuki Sakamoto
Johnson & Johnson K.K. Medical Company Clinical Development Clinical Operation
Outcome results
None listed