Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty
- Conditions
- Osteoarthritis - Non-inflammatory Joint Disease100059421002321310005944
- Registration Number
- NL-OMON44724
- Lead Sponsor
- DePuy Synthes Joint Reconstruction, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 208
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 resulting from osteoarthritis (OA) or post-traumatic arthritis.
c) Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
d) Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction (see Section 6.3.2).
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 procedure and follow-up visits and co-operate with investigational procedures.
g) Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the PROs in the CIP in either Dutch or English translations.
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, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
e) Subject is currently experiencing 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 months.
g) Subject is currently involved in any personal injury litigation, medical-legal or worker*s compensation claims.
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 3 years of life expectancy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in this study is the KOOS-PS change from baseline to 6<br /><br>months post-operatively, as estimated from a repeated measurements longitudinal<br /><br>model over all post-operative time points.</p><br>
- Secondary Outcome Measures
Name Time Method