NCT03146819

A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Detailed description

This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	iTotal PS Knee Replacement System	Total Knee Replacement systems (Patient Specific)
DEVICE	Off-the-Shelf Knee Replacement System	Total Knee Replacement systems (Off-the-shelf)

Timeline

• Start date: 2016-12-16
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2017-05-10
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study