Overview

This trial is active, not recruiting.

Conditions osteoarthritis, varus malalignment
Treatment ellipse im hto nail
Sponsor Ellipse Technologies, Inc.
Start date July 2015
End date June 2016
Trial size 40 participants
Trial identifier NCT02412163, PR0123

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implant with the Ellipse IM HTO Nail
ellipse im hto nail

Primary Outcomes

Measure
Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
time frame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)

Secondary Outcomes

Measure
Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation
time frame: Week 6 (Considered the Final Correction Visit unless additional visits are required), Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target
time frame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Change in Hip-Knee-Ankle Angle Baseline versus Final Correction
time frame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation
time frame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Change in Tibial Slope Angle Baseline versus Final Correction
time frame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Change in Tibial Slope Angle Baseline versus Final Consolidation
time frame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Time to Full Weight-Bearing
time frame: Week 2, Week 4, Week 6, Month 3, Month 6

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter Study of Patients Treated With the Ellipse Technologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee
Principal investigator Mark T Dahl, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ellipse Technologies, Inc..