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

Completed

• Conditions: Osteoarthritis, Knee; Knee Osteoarthritis
• Interventions: Device: ConforMIS iUni, iDuo, or iTotal (CR)

• Registration Number: NCT03152357
• Lead Sponsor: Restor3D

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-15
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients implanted with a ConforMIS device	ConforMIS iUni, iDuo, or iTotal (CR)	Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement

Primary Outcome Measures

Name	Time	Method
Survivorship data	1 year	Survivorship of the implant--whether or not the patient has had a surgical revision prior to data collection.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Preferred Orthopedics of the Palm Beaches; 🇺🇸 Boynton Beach, Florida, United States