Osteoarthritis, Varus Malalignment
Conditions
Brief summary
This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.
Detailed description
The Ellipse IM HTO Nail is intended for open wedge proximal tibial osteotomies. The Ellipse IM HTO Nail is an intramedullary nail that operates on the principles of distraction osteogenesis. The Ellipse IM HTO Nail is used in valgizing HTO procedures to correct varus malalignment. The Ellipse IM HTO Nail is surgically placed in the intramedullary canal of the tibia. It is lengthened telescopically using the non-invasive external remote control.
Interventions
DEVICEEllipse IM HTO Nail
Sponsors
Ellipse Technologies, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has standing varus malalignment benefitting from high tibial osteotomy correction 2. Patient is diagnosed with current osteoarthritis of the knee 3. Patient is eighteen years of age or greater 4. Patient is a candidate to be implanted with an Ellipse IM HTO System 5. If female of childbearing potential, patient presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study 6. Patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements 7. Patient signs informed consent for the use of their personal private data
Exclusion criteria
1. Patient declines to sign informed consent for the use of their personal private data 2. Varus deformity greater than 10° 3. Flexion contracture greater than 15° 4. Knee flexion under 90° 5. Medial/lateral tibial subluxation over 1 cm 6. Medial bone loss of over 3 mm 7. Inflammatory arthritis 8. Arthritis in the lateral compartment 9. Patella baja 10. Weight over 114 kg 11. Severe patellofemoral symptoms 12. Unaddressed ligamentous instability 13. Fixed flexion contracture 14. Known or suspected osteoporosis or osteopenia based on medical history and radiographic images 15. Current use of nicotine products. 16. Requires other surgical procedures at the time of the HTO surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | Baseline Target versus Final Target |
| Change in Hip-Knee-Ankle Angle Baseline versus Final Correction | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) | Baseline versus Final Correction |
| Change in Tibial Slope Angle Baseline versus Final Correction | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) | Baseline versus Final Correction |
| Change in Tibial Slope Angle Baseline versus Final Consolidation | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | Baseline versus Final Consolidation |
| Time to Full Weight-Bearing | Week 2, Week 4, Week 6, Month 3, Month 6 | Amount of time required until a patient is allowed to put 100% of their body weight on the leg. |
| Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | — |
| Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation | Week 6 (Considered the Final Correction Visit unless additional visits are required), Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Non-Serious Adverse Events | Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6 | Incidence of Non-Serious Adverse Events upon enrollment into the study |
| Secondary Surgical Procedures | Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6 | Incidence of Secondary Surgical Procedures upon enrollment into the study |
| Serious Adverse Events | Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6 | Incidence of Serious Adverse Events upon enrollment into the study |
| Unanticipated Adverse Device Effects | Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6 | Incidence of Unanticipated Adverse Effects upon enrollment into the study |
Countries
Germany, Netherlands, Poland, United Kingdom
Outcome results
None listed