N/A
N=89
A Retrospective Study of the iTotal CR Knee Replacement System
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01564654 ↗Enrolled (actual)
89
Serious AEs
5.6%
Results posted
Jan 2021
Primary outcome: Primary: Knee Function — 113 degrees
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- iTotal KRS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Restor3D
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Function |
113 | — |
| SECONDARY Revision Rate |
1 | — |
| SECONDARY Number of Transfusions |
— | — |
| SECONDARY Manipulations Under Anesthesia |
4 | — |
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.
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.