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

restor3d

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Device: iTotal Posterior Stabilized (PS) Knee Replacement System

Study type: Observational

Funder types: Industry

Identifiers

NCT03289000

16-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

93 participants in 1 patient group

ConforMIS PS Group

Description:

Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System

Treatment:

Device: iTotal Posterior Stabilized (PS) Knee Replacement System