Osteoarthritis, Varus Malalignment
Conditions
Brief summary
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
Interventions
DEVICEEllipse Technologies Intramedullary High Tibial Osteotomy Nail System
Sponsors
Ellipse Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee * Patient signs informed consent for the use of their personal private data.
Exclusion criteria
* Patient is currently enrolled in another clinical trial for high tibial osteotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vs. Actual Correction | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks | Measured as either weight-bearing line (percent) or HKA angle (degrees) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hip-Knee-Ankle Angle | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks | Measured in degrees |
| Change in Weight-Bearing Line | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks | Measured in percent |
| Change in Tibial Slope | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks | Measured in degrees |
| Time to full weight-bearing | Participants will be followed through 2 years post-operative | Measured in days |
| Bone Healing | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks | Graded 0 through 2, corresponding to Not Healing, Healing, and Healed |
Other
| Measure | Time frame |
|---|---|
| Secondary surgical procedures | Participants will be followed through 2 years post-operative |
| Surgical complications | Participants will be followed through 2 years post-operative |
| All non-serious adverse events in the limb related to the device or study procedure. Study procedure includes implant procedure and correction lengthening procedure. | Participants will be followed through 2 years post-operative |
| All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) | Participants will be followed through 2 years post-operative |
Outcome results
None listed