Ellipse Intramedullary Nail High Tibial Osteotomy Study

Completed

• Conditions: Osteoarthritis; Varus Malalignment
• Interventions: Device: Ellipse IM HTO Nail

• Registration Number: NCT02412163
• Lead Sponsor: Ellipse Technologies, Inc.

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.

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Study Start: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IM HTO Nail	Ellipse IM HTO Nail	Implant with the Ellipse IM HTO Nail

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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
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
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)

Trial Locations

Locations (11)

Lekmed Hospital; 🇵🇱 Warsaw, Poland

District Hospital of Wolomin; 🇵🇱 Wolomin, Poland

Zagiel Hospital; 🇵🇱 Lublin, Poland

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

North Cumbria University Hospital; 🇬🇧 Carlisle, United Kingdom

Medizinische Hochschule; 🇩🇪 Hannover, Germany

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

Centrum Ortopedii I Traumatologii; 🇵🇱 Bialystok, Poland

University Hospital Aintree; 🇬🇧 Liverpool, United Kingdom

University Hospitals Southampton; 🇬🇧 Southampton, United Kingdom