NCT03152162

A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

Detailed description

The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	iTotal PS KRS	Total knee arthroplasty for treatment of osteoarthritis

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2017-05-12
• Last updated: 2023-10-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study