A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Demographics and Medical History
Study Overview
Brief Summary
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.
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.
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Demographics and Medical History
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Pre & Post-Operative Data including Range of Motion
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Surgical Data
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Survivorship (phone/email or last known visit)
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Patient Reported Outcomes (phone/email single time point visit)
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Patient Satisfaction
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KOOS Jr.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
- •Over 18 Years of age
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Demographics and Medical History
Time Frame: 1 year
Demographics and medical history gathered from medical records
Pre and Post Operative Range of Motion
Time Frame: 1 year
Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
Secondary Outcomes
No secondary outcomes reported