Osteo Arthritis Knee
Conditions
Keywords
osteoarthritis, knee arthroplasty, knee replacement, patient specific
Brief summary
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.
Detailed description
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. . All data will be collected from existing medical records and from single follow up call/email. * Demographics and Medical History * Pre & Post-Operative Data including Range of Motion * Surgical Data * Survivorship (phone/email or last known visit) * Patient Reported Outcomes (phone/email single time point visit) * Patient Satisfaction * KOOS Jr.
Interventions
DEVICEiTotal Posterior Stabilized (PS) Knee Replacement System
Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs
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
1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement. 2. Over 18 Years of age
Exclusion criteria
1\. BMI \> 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics and Medical History | 1 year | Demographics and medical history gathered from medical records |
| Pre and Post Operative Range of Motion | 1 year | Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits |
Countries
United States
Outcome results
None listed