Knee Osteoarthritis, Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, total knee arthroplasty, TKA, TKR, patient specific, Conformis
Brief summary
This study is designed to evaluate implant survivorship, patient satisfaction, and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.
Detailed description
This study is designed to evaluate implant survivorship, patient satisfaction and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.This study is a retrospective, single-center study, with one single remote follow up contact. Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available.
Interventions
DEVICEConforMIS iUni, iDuo, or iTotal (CR)
ConforMIS iUni, iDuo, or iTotal (CR)
Sponsors
Restor3D
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement. * Subject must be greater than 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship data | 1 year | Survivorship of the implant--whether or not the patient has had a surgical revision prior to data collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes | 1 year | Collected via questionnaires during either an in-office visit or a phone call. The questionnaires are aimed at gauging how satisfied the patient is with the function of their device, if and when they experience pain/stiffness, and if and how their activities of daily living have have been affected. |
Countries
United States
Outcome results
None listed