Ellipse Intramedullary Nail High Tibial Osteotomy Study

NCT02412163 | Completed FDA Device

• 1 other identifier: PR0123
• Study Type: observational
• Target: 41
• Locations: 4 countries
• Sites: 11

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.

Conditions

Osteoarthritis; Varus Malalignment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Change in Hip-Knee-Ankle Angle 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

  Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)

Other Outcomes (4)

• Serious Adverse Events

  Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

• Unanticipated Adverse Device Effects

  Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

• Non-Serious Adverse Events

  Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

Study Arms (1)

IM HTO Nail

Implant with the Ellipse IM HTO Nail

Device: Ellipse IM HTO Nail

Interventions

Ellipse IM HTO Nail DEVICE

IM HTO Nail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient has standing varus malalignment benefitting from high tibial osteotomy correction
• Patient is diagnosed with current osteoarthritis of the knee
• Patient is eighteen years of age or greater
• Patient is a candidate to be implanted with an Ellipse IM HTO System
• 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
• Patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements
• Patient signs informed consent for the use of their personal private data

You may not qualify if:

• Patient declines to sign informed consent for the use of their personal private data
• Varus deformity greater than 10°
• Flexion contracture greater than 15°
• Knee flexion under 90°
• Medial/lateral tibial subluxation over 1 cm
• Medial bone loss of over 3 mm
• Inflammatory arthritis
• Arthritis in the lateral compartment
• Patella baja
• Weight over 114 kg
• Severe patellofemoral symptoms
• Unaddressed ligamentous instability
• Fixed flexion contracture
• Known or suspected osteoporosis or osteopenia based on medical history and radiographic images
• Current use of nicotine products.

Sponsors & Collaborators

• Ellipse Technologies, Inc.: lead

Study Sites (11)

Medizinische Hochschule

Hanover, Germany

Location

Martini Ziekenhuis

Groningen, 9728, Netherlands

Location

Isala Klinieken

Zwolle, 8025, Netherlands

Location

Centrum Ortopedii I Traumatologii

Bialystok, Poland

Location

Zagiel Hospital

Lublin, Poland

Location

Lekmed Hospital

Warsaw, 01-480, Poland

Location

District Hospital of Wolomin

Wołomin, Poland

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

North Cumbria University Hospital

Carlisle, CA2 7HY, United Kingdom

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

University Hospitals Southampton

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark T Dahl, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 1, 2017

Record last verified: 2017-06

Locations

GB (4); PL (4); NL (2); DE (1)