Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.
Interventions
DEVICEP.F.C. Sigma PS150 RP Total Knee System
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant
Sponsors
DePuy Orthopaedics
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant. * Signed Informed Patient Consent
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship | 5 years | Lack of revision with revision meaning no removal or replacement of any TKA component. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score - Knee Score | 1, 3 & 5 years | Descriptive statistics, including change from baseline (post-op minus pre-op) |
| Knee Society Score - Function | 1, 3 & 5 years | Descriptive statistics, including change from baseline (post-op minus pre-op) |
| Pain sub-question of the Knee Society Score | 1, 3 & 5 years | Descriptive statistics, including change from baseline (post-op minus pre-op) |
| Flexion | 1, 3 & 5 years | Descriptive statistics, including change from baseline (post-op minus pre-op) |
| Extension | 1, 3 & 5 years | Descriptive statistics, including change from baseline (post-op minus pre-op) |
| Radiographic Analysis | 1, 3 & 5 years | Descriptive statistics |
| Adverse Events | 1, 3 & 5 years | Type and frequency of adverse events |
Countries
Australia, South Korea
Outcome results
None listed