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

restor3d

Status: Terminated

Conditions: Osteoarthritis, Knee

Treatments: Device: iTotal PS Knee Replacement System; Device: Off-the-Shelf Knee Replacement System

Study type: Observational

Funder types: Industry

Identifiers

NCT03146819

15-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implant must be a minimum of 6 months post-op and doing well in the opinion of site staff
• Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
• > 18 years of age
• Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations

Exclusion criteria

• Simultaneous or staged bilateral procedure
• BMI > 40
• Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
• Participation in another clinical study which would confound results
• Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Trial design

31 participants in 2 patient groups

iTotal PS KRS

Description:

Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing.

Treatment:

Device: iTotal PS Knee Replacement System

Off-the-Shelf KRS

Description:

Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing.

Treatment:

Device: Off-the-Shelf Knee Replacement System