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

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Device: iTotal Posterior Stabilized (PS) Knee Replacement System

• Registration Number: NCT03289000
• Lead Sponsor: Restor3D

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-24
• Primary Completion: 2017-08-04
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Completion: 2017-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ConforMIS PS Group	iTotal Posterior Stabilized (PS) Knee Replacement System	Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System

Primary Outcome Measures

Name	Time	Method
Demographics and Medical History	1 year	Demographics and medical history gathered from medical records
Pre and Post Operative Range of Motion	1 year	Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits

Trial Locations

Locations (2)

Tennessee Orthopaedic Alliance; 🇺🇸 Nashville, Tennessee, United States

Scott Orthopedic Center; 🇺🇸 Huntington, West Virginia, United States