Skip to main content
OpenTrials
Completed

NCT Number: NCT03152357

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Preferred Orthopedics of the Palm Beaches

Boynton Beach, Florida, 33437, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

ConforMIS iUni, iDuo, or iTotal (CR)

Device

ConforMIS iUni, iDuo, or iTotal (CR)

Primary outcomes

  1. Survivorship data

    Time frame: 1 year

    Survivorship of the implant--whether or not the patient has had a surgical revision prior to data collection.

Secondary outcomes

  1. Patient Reported Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 15, 2017
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.