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

Terminated

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT03146819
• Lead Sponsor: Restor3D

Brief 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.

Study Timeline

• Study Start: 2016-12-16
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional testing differences	At least 6 months post-surgery	Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants

Secondary Outcome Measures

Name	Time	Method
Knee Society Clinical Rating Score	At least 6 months post-surgery	Comparison of scores and sub-scores from the following questionnaires between the study arms
The Knee Injury and Osteoarthritis Outcome Score (KOOS)	At least 6 months post-surgery	Comparison of scores and sub-scores from the following questionnaires between the study arms

Trial Locations

Locations (1)

Bethesda Orthopedic; 🇺🇸 Bethesda, Maryland, United States