Ellipse Intramedullary Nail High Tibial Osteotomy Study

Osteoarthritis Clinical Trial

— IM HTO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412163
• Other study ID #: PR0123
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: August 31, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Varus Malalignment

Intervention

Device:
• Ellipse IM HTO Nail

Locations

Country	Name	City	State
Germany	Medizinische Hochschule	Hannover
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Isala Klinieken	Zwolle
Poland	Centrum Ortopedii I Traumatologii	Bialystok
Poland	Zagiel Hospital	Lublin
Poland	Lekmed Hospital	Warsaw
Poland	District Hospital of Wolomin	Wolomin
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	North Cumbria University Hospital	Carlisle
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	University Hospitals Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious Adverse Events	Incidence of Serious Adverse Events upon enrollment into the study	Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
Other	Unanticipated Adverse Device Effects	Incidence of Unanticipated Adverse Effects upon enrollment into the study	Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
Other	Non-Serious Adverse Events	Incidence of Non-Serious Adverse Events upon enrollment into the study	Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
Other	Secondary Surgical Procedures	Incidence of Secondary Surgical Procedures upon enrollment into the study	Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
Primary	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	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)
Secondary	Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target	Baseline Target versus Final Target	Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Secondary	Change in Hip-Knee-Ankle Angle Baseline versus Final Correction	Baseline versus Final Correction	Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Secondary	Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation		Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Secondary	Change in Tibial Slope Angle Baseline versus Final Correction	Baseline versus Final Correction	Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Secondary	Change in Tibial Slope Angle Baseline versus Final Consolidation	Baseline versus Final Consolidation	Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Secondary	Time to Full Weight-Bearing	Amount of time required until a patient is allowed to put 100% of their body weight on the leg.	Week 2, Week 4, Week 6, Month 3, Month 6

External Links

•   Sponsor Website