Ellipse Intramedullary Nail High Tibial Osteotomy Study (IM HTO)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Varus Malalignment
• Intervention / Treatment: Device: Ellipse IM HTO Nail

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Medizinische Hochschule
• Netherlands
  • Groningen, Netherlands, 9728
    • Martini Ziekenhuis
  • Zwolle, Netherlands, 8025
    • Isala Klinieken
• Poland
  • Bialystok, Poland
    • Centrum Ortopedii I Traumatologii
  • Lublin, Poland
    • Zagiel Hospital
  • Warsaw, Poland, 01-480
    • Lekmed Hospital
  • Wolomin, Poland
    • District Hospital of Wolomin
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • North Bristol NHS Trust
  • Carlisle, United Kingdom, CA2 7HY
    • North Cumbria University Hospital
  • Liverpool, United Kingdom, L9 7AL
    • University Hospital Aintree
  • Southampton, United Kingdom, SO16 6YD
    • University Hospitals Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the protocol eligibility criteria including standing varus malalignment in the limb presenting with osteoarthritis of the knee.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IM HTO Nail; Implant with the Ellipse IM HTO Nail	Device: Ellipse IM HTO Nail

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline Target versus Final Target	Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
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)
Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation		Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
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)
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)
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Ellipse Technologies, Inc.
• Investigators: Principal Investigator: Mark T Dahl, MD, University of Minnesota

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: PR0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes