OsteoarthritisNCT02519218
Ellipse Intramedullary High Tibial Osteotomy Nail Study
An observational study of Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc..
Trial summary
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Varus Malalignment
- What is being tested?
- Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.
Who may be able to join
- 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.
Who cannot join
- Patient is currently enrolled in another clinical trial for high tibial osteotomy.
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Varus Malalignment
- Being tested
- Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipse Technologies Intramedullary High Tibial Osteotomy Nail SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vs. Actual Correction
Measured as either weight-bearing line (percent) or HKA angle (degrees)
Measured: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Target vs. Actual Correction
Measured as either weight-bearing line (percent) or HKA angle (degrees)
Measured: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Secondary outcomes (17)
Change in Weight-Bearing Line
Measured in percent
Measured: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Weight-Bearing Line
Measured in percent
Measured: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Weight-Bearing Line
Measured in percent
Measured: 1-year post-operative
Change in Weight-Bearing Line
Measured in percent
Measured: 2-years post-operative
Change in Hip-Knee-Ankle Angle
Measured in degrees
Measured: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Hip-Knee-Ankle Angle
Measured in degrees
Measured: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Hip-Knee-Ankle Angle
Measured in degrees
Measured: 1-year post-operative
Change in Hip-Knee-Ankle Angle
Measured in degrees
Measured: 2-years post-operative
Change in Tibial Slope
Measured in degrees
Measured: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Tibial Slope
Measured in degrees
Measured: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Tibial Slope
Measured in degrees
Measured: 1-year post-operative
Change in Tibial Slope
Measured in degrees
Measured: 2 years post-operative
Time to full weight-bearing
Measured in days
Measured: Participants will be followed through 2 years post-operative
Bone Healing
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
Measured: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Bone Healing
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
Measured: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Bone Healing
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
Measured: 1-year post-operative
Bone Healing
Graded 0 through 2, corresponding to Not Healing, Healing, and Healed
Measured: 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Dahl, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519218
- Sponsor's protocol ID
- PR0179
- Status last verified
- Jan 2018
- First submitted
- 5 Aug 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System
- ClinicalTrials.gov ID
- NCT02519218
- Acronym / sponsor ID
- PR0179
- Conditions
- Osteoarthritis, Varus Malalignment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient is currently enrolled in another clinical trial for high tibial osteotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System | Device | – |
Primary outcome
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)
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)
17 secondary outcomes
Change in Weight-Bearing Line
Time frame: 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
Change in Weight-Bearing Line
Time frame: 1-year post-operative
Change in Weight-Bearing Line
Time frame: 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
Change in Hip-Knee-Ankle Angle
Time frame: 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
Change in Hip-Knee-Ankle Angle
Time frame: 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
Change in Tibial Slope
Time frame: 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
Change in Tibial Slope
Time frame: 2 years post-operative
Time to full weight-bearing
Time frame: 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
Bone Healing
Time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Bone Healing
Time frame: 1-year post-operative
Bone Healing
Time frame: 2 years post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Dahl, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vs. Actual Correction (time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.