Osteoarthritis
Conditions
Brief 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.
Interventions
DEVICEiTotal KRS
Total Knee Replacement System
Sponsors
Restor3D
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical condition included in the approved Indications For Use 2. Has signed the informed consent form to allow review of medical records and collection of data therein. 3. \> 18 years of age
Exclusion criteria
1. Treatment with iTotal in a manner inconsistent with Instructions for Use 2. Unwilling to sign then informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Function | Average of 7 months post-operative | Range of Motion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision Rate | Average of 7 months | Number of knees that required a reoperation to remove/replace/add implant components |
| Number of Transfusions | Initial hospital stay | Number of knees that required a blood transfusion during the initial hospital stay post-operative |
| Manipulations Under Anesthesia | Up to 7 months post-operative | Number of knees that required a subsequent procedure to restore knee range of motion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iTotal KRS iTotal KRS: Total Knee Replacement System | 89 |
| Total | 89 |
Baseline characteristics
| Characteristic | iTotal KRS |
|---|---|
| Age, Customized Mean age at surgery | 68 years |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 5 / 89 |
Outcome results
Primary
Knee Function
Range of Motion
Time frame: Average of 7 months post-operative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iTotal KRS | Knee Function | 113 degrees |
Secondary
Manipulations Under Anesthesia
Number of knees that required a subsequent procedure to restore knee range of motion
Time frame: Up to 7 months post-operative
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iTotal KRS | Manipulations Under Anesthesia | 4 Knees |
Secondary
Number of Transfusions
Number of knees that required a blood transfusion during the initial hospital stay post-operative
Time frame: Initial hospital stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iTotal KRS | Number of Transfusions | 0 number of knees requiring transfusion |
Secondary
Revision Rate
Number of knees that required a reoperation to remove/replace/add implant components
Time frame: Average of 7 months
Population: bilaterals were included
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iTotal KRS | Revision Rate | 1 Knees |