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Completed

NCT Number: NCT02519218

Ellipse Intramedullary High Tibial Osteotomy Nail Study

The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Varus Malalignment

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee
  • Patient signs informed consent for the use of their personal private data.

Exclusion criteria

  • Patient is currently enrolled in another clinical trial for high tibial osteotomy.

Treatment and study plan

Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System

Device

Primary outcomes

  1. Target vs. Actual Correction

    Time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks

    Measured as either weight-bearing line (percent) or HKA angle (degrees)

  2. Target vs. Actual Correction

    Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

    Measured as either weight-bearing line (percent) or HKA angle (degrees)

Secondary outcomes

  1. Change in Weight-Bearing Line

    Time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks

    Measured in percent

  2. Change in Weight-Bearing Line

    Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

    Measured in percent

  3. Change in Weight-Bearing Line

    Time frame: 1-year post-operative

    Measured in percent

  4. Change in Weight-Bearing Line

    Time frame: 2-years post-operative

    Measured in percent

  5. Change in Hip-Knee-Ankle Angle

    Time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks

    Measured in degrees

  6. Change in Hip-Knee-Ankle Angle

    Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

    Measured in degrees

  7. Change in Hip-Knee-Ankle Angle

    Time frame: 1-year post-operative

    Measured in degrees

  8. Change in Hip-Knee-Ankle Angle

    Time frame: 2-years post-operative

    Measured in degrees

  9. Change in Tibial Slope

    Time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks

    Measured in degrees

  10. Change in Tibial Slope

    Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

    Measured in degrees

  11. Change in Tibial Slope

    Time frame: 1-year post-operative

    Measured in degrees

  12. Change in Tibial Slope

    Time frame: 2 years post-operative

    Measured in degrees

  13. Time to full weight-bearing

    Time frame: Participants will be followed through 2 years post-operative

    Measured in days

  14. Bone Healing

    Time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks

    Graded 0 through 2, corresponding to Not Healing, Healing, and Healed

  15. Bone Healing

    Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

    Graded 0 through 2, corresponding to Not Healing, Healing, and Healed

  16. Bone Healing

    Time frame: 1-year post-operative

    Graded 0 through 2, corresponding to Not Healing, Healing, and Healed

  17. Bone Healing

    Time frame: 2 years post-operative

    Graded 0 through 2, corresponding to Not Healing, Healing, and Healed

Other outcomes

  1. All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)

    Time frame: Participants will be followed through 2 years post-operative

  2. All non-serious adverse events in the limb related to the device or study procedure. Study procedure includes implant procedure and correction lengthening procedure.

    Time frame: Participants will be followed through 2 years post-operative

  3. Secondary surgical procedures

    Time frame: Participants will be followed through 2 years post-operative

  4. Surgical complications

    Time frame: Participants will be followed through 2 years post-operative

Sponsors and collaborators

Lead sponsor

Ellipse Technologies, Inc.

Industry

Registry information

Official study title

Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2015
Registry last updated
Feb 1, 2018

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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