A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

Osteo Arthritis Knee Clinical Trial

Official title:

A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289000
• Other study ID #: 16-004
• Status: Completed
• Start date: April 24, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. . All data will be collected from existing medical records and from single follow up call/email.

• Demographics and Medical History

• Pre & Post-Operative Data including Range of Motion

• Surgical Data

• Survivorship (phone/email or last known visit)

• Patient Reported Outcomes (phone/email single time point visit)

• Patient Satisfaction

• KOOS Jr.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 31, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.

2. Over 18 Years of age

Exclusion Criteria:

1. BMI > 40

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• iTotal Posterior Stabilized (PS) Knee Replacement System
Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

Locations

Country	Name	City	State
United States	Scott Orthopedic Center	Huntington	West Virginia
United States	Tennessee Orthopaedic Alliance	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics and Medical History	Demographics and medical history gathered from medical records	1 year
Primary	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