Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152357
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Knee Osteoarthritis Device: ConforMIS iUni, iDuo, or iTotal (CR)

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 950 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® CR (Cruciate Retaining) Knee Replacement Systems
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients implanted with a ConforMIS device
Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement
Device: ConforMIS iUni, iDuo, or iTotal (CR)
ConforMIS iUni, iDuo, or iTotal (CR)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient's over 18 that have undergone surgical implantation of a ConforMIS product
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152357


Locations
Layout table for location information
United States, Florida
Preferred Orthopedics of the Palm Beaches
Boynton Beach, Florida, United States, 33437
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Gregory Martin, MD JFK Medical Center
Publications:
Layout table for additonal information
Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT03152357    
Other Study ID Numbers: 16-003
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ConforMIS, Inc.:
osteoarthritis
total knee arthroplasty
TKA
TKR
patient specific
Conformis
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases