NCT03289000

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	iTotal Posterior Stabilized (PS) Knee Replacement System	Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

Timeline

• Start date: 2017-04-24
• Primary completion: 2017-08-04
• Completion: 2017-12-31
• First posted: 2017-09-20
• Last updated: 2023-10-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study