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

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: iTotal Posterior Stabilized (PS) Knee Replacement System

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.

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Orthopaedic Alliance
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • Scott Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.

Description

Inclusion Criteria:

1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
2. Over 18 Years of age

Exclusion Criteria:

1. BMI > 40

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ConforMIS PS Group; Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System	Device: iTotal Posterior Stabilized (PS) Knee Replacement System; Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics and Medical History	Demographics and medical history gathered from medical records	1 year
Pre and Post Operative Range of Motion	Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits	1 year

Collaborators and Investigators

• Sponsor: Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): August 4, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; patient specific; knee replacement; knee arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 16-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes