NCT03289000

Brief Summary

This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 15, 2017

Last Update Submit

October 23, 2023

Conditions

Osteo Arthritis Knee

Keywords

osteoarthritisknee arthroplastyknee replacementpatient specific

Outcome Measures

Primary Outcomes (2)

  • Demographics and Medical History

    Demographics and medical history gathered from medical records

    1 year

  • Pre and Post Operative Range of Motion

    Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits

    1 year

Study Arms (1)

ConforMIS PS Group

Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System

Device: iTotal Posterior Stabilized (PS) Knee Replacement System

Interventions

iTotal Posterior Stabilized (PS) Knee Replacement SystemDEVICE

Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

ConforMIS PS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.

You may qualify if:

  • Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
  • Over 18 Years of age

You may not qualify if:

  • \. BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203, United States

Location

Scott Orthopedic Center

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 20, 2017

Study Start

April 24, 2017

Primary Completion

August 4, 2017

Study Completion

December 31, 2017

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

US(2)