A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS

restor3d

Status: Completed

Conditions: Knee Osteoarthritis; Osteoarthritis, Knee

Treatments: Device: ConforMIS iUni, iDuo, or iTotal (CR)

Study type: Observational

Funder types: Industry

Identifiers

NCT03152357

16-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 950 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement.
• Subject must be greater than 18 years of age.

Trial design

950 participants in 1 patient group

Patients implanted with a ConforMIS device

Description:

Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement

Treatment:

Device: ConforMIS iUni, iDuo, or iTotal (CR)