N/A
Completed N=89
A Retrospective Study of the iTotal CR Knee Replacement System
Source: ClinicalTrials.gov NCT01564654 ↗Enrolled (actual)
89
Serious AEs
5.6%
Results posted
Jan 2021
Primary outcomePrimary: Knee Function — 113 degrees
Summary
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Function |
113 | — |
| SECONDARY Revision Rate |
1 | — |
| SECONDARY Number of Transfusions |
— | — |
| SECONDARY Manipulations Under Anesthesia |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical condition included in the approved Indications For Use
- Has signed the informed consent form to allow review of medical records and collection of data therein.
- > 18 years of age
Exclusion Criteria
- Treatment with iTotal in a manner inconsistent with Instructions for Use
- Unwilling to sign then informed consent form
Data sourced from ClinicalTrials.gov (NCT01564654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.