NCT03152357

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

A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® CR (Cruciate Retaining) Knee Replacement Systems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 950 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ConforMIS iUni, iDuo, or iTotal (CR)	ConforMIS iUni, iDuo, or iTotal (CR)

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-09-01
• Completion: 2019-12-31
• First posted: 2017-05-15
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study