Total Knee Arthroplasty
Conditions
Keywords
Legion
Brief summary
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith & Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.
Interventions
DEVICELEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component
LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis). 2. Subject received primary TKA between 24 and 60 months prior to the time of consent. Inclusion criteria for prospective follow-up (subjects must meet criteria 1 \& 2 from above and criteria 3,4 and 5 below): 3. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form. 4. Subject must be available through ten (10) years postoperative follow-up. 5. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant survivorship 10 years post-surgery | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - KOOS JR | 10 years | Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire |
| Quality of Life - Forgotten Joint Score (FJS) | 10 years | Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire |
| Quality of life - EQ-5D-5L | 10 years | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire |
| Implant survivorship | 5 years | Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision |
| Radiographic findings | 10 years | X-ray of implanted knee- 3 views (AP, Lateral and Skyline/Merchant) to observe any radiographic findings that may include; Heterotopic ossification, oteolysis, femoral notching, evidence of poly wear, radiolucencies. |
Countries
United States
Contacts
STUDY_CHAIRKarlie Morgan
Smith & Nephew, Inc.
Outcome results
None listed