An observational study in Osteo Arthritis Knee, sponsored by Restor3D. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Restor3D · Observational
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.
Patient Reported Outcomes (phone/email single time point visit)
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.
Exclusion Criteria:
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
Demographics and Medical History
Demographics and medical history gathered from medical records
Time frame: 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
Time frame: 1 year
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Restor3D