Ellipse Intramedullary High Tibial Osteotomy Nail Study

January 30, 2018 updated by: Ellipse Technologies, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
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)
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
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
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Weight-Bearing Line
Time Frame: 1-year post-operative
Measured in percent
1-year post-operative
Change in Weight-Bearing Line
Time Frame: 2-years post-operative
Measured in percent
2-years post-operative
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
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
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
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Hip-Knee-Ankle Angle
Time Frame: 1-year post-operative
Measured in degrees
1-year post-operative
Change in Hip-Knee-Ankle Angle
Time Frame: 2-years post-operative
Measured in degrees
2-years post-operative
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
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
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
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Tibial Slope
Time Frame: 1-year post-operative
Measured in degrees
1-year post-operative
Change in Tibial Slope
Time Frame: 2 years post-operative
Measured in degrees
2 years post-operative
Time to full weight-bearing
Time Frame: Participants will be followed through 2 years post-operative
Measured in days
Participants will be followed through 2 years post-operative
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
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
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
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Bone Healing
Time Frame: 1-year post-operative
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
1-year post-operative
Bone Healing
Time Frame: 2 years post-operative
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
2 years post-operative

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time Frame: Participants will be followed through 2 years post-operative
Participants will be followed through 2 years post-operative
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
Participants will be followed through 2 years post-operative
Secondary surgical procedures
Time Frame: Participants will be followed through 2 years post-operative
Participants will be followed through 2 years post-operative
Surgical complications
Time Frame: Participants will be followed through 2 years post-operative
Participants will be followed through 2 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ellipse Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Dahl, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR0179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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