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



Status:Completed
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/11/2018
Start Date:April 24, 2017
End Date:December 31, 2017

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Trial Summary
Trial Overview
Inclusion Criteria
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.

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.

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
We found this trial at
2
sites
Scott Orthopedic Center
Huntington, West Virginia 25702
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from
Huntington, WV
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Tennessee Orthopaedic Alliance
Nashville, Tennessee 37205
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from
Nashville, TN
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