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Completed

NCT Number: NCT02412163

Ellipse Intramedullary Nail High Tibial Osteotomy Study

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Varus Malalignment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule, Hanover, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Requires other surgical procedures at the time of the HTO surgery

Treatment and study plan

Ellipse IM HTO Nail

Device

Primary outcomes

  1. 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

  1. 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)

  2. 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)

    Baseline Target versus Final Target

  3. 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)

    Baseline versus Final Correction

  4. 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)

  5. 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)

    Baseline versus Final Correction

  6. 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)

    Baseline versus Final Consolidation

  7. Time to Full Weight-Bearing

    Time frame: 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.

Other outcomes

  1. Serious Adverse Events

    Time frame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

    Incidence of Serious Adverse Events upon enrollment into the study

  2. Unanticipated Adverse Device Effects

    Time frame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

    Incidence of Unanticipated Adverse Effects upon enrollment into the study

  3. Non-Serious Adverse Events

    Time frame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

    Incidence of Non-Serious Adverse Events upon enrollment into the study

  4. Secondary Surgical Procedures

    Time frame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6

    Incidence of Secondary Surgical Procedures upon enrollment into the study

Sponsors and collaborators

Lead sponsor

Ellipse Technologies, Inc.

Industry

Registry information

Official study 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

Acronym: IM HTO

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 9, 2015
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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