OsteoarthritisIM HTONCT02412163
Ellipse Intramedullary Nail High Tibial Osteotomy Study
An observational study of Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc. at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Varus Malalignment
- What is being tested?
- Ellipse IM HTO Nail
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Jul 2015to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who meet the protocol eligibility criteria including standing varus malalignment in the limb presenting with osteoarthritis of the knee.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Poland4 sites
Centrum Ortopedii I Traumatologii
Bialystok
Zagiel Hospital
Lublin
Lekmed Hospital
Warsaw, 01-480
District Hospital of Wolomin
Wołomin
United Kingdom4 sites
North Bristol NHS Trust
Bristol, BS10 5NB
North Cumbria University Hospital
Carlisle, CA2 7HY
University Hospital Aintree
Liverpool, L9 7AL
University Hospitals Southampton
Southampton, SO16 6YD
Netherlands2 sites
Martini Ziekenhuis
Groningen, 9728
Isala Klinieken
Zwolle, 8025
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Varus Malalignment
- Being tested
- Ellipse IM HTO Nail
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipse IM HTO NailDevice
| Study group | Role | What they receive |
|---|---|---|
| IM HTO Nail | Implant with the Ellipse IM HTO Nail Receives: Device: Ellipse IM HTO Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
Measured: 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
Measured: 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
Baseline Target versus Final Target
Measured: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Change in Hip-Knee-Ankle Angle Baseline versus Final Correction
Baseline versus Final Correction
Measured: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation
Measured: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Change in Tibial Slope Angle Baseline versus Final Correction
Baseline versus Final Correction
Measured: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Change in Tibial Slope Angle Baseline versus Final Consolidation
Baseline versus Final Consolidation
Measured: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
Time to Full Weight-Bearing
Amount of time required until a patient is allowed to put 100% of their body weight on the leg.
Measured: Week 2, Week 4, Week 6, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionDec 2016
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark T Dahl, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412163
- Sponsor's protocol ID
- PR0123
- Acronym
- IM HTO
- Status last verified
- Jun 2017
- First submitted
- 1 Apr 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02412163
- Acronym / sponsor ID
- IM HTO / PR0123
- Conditions
- Osteoarthritis, Varus Malalignment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM HTO Nail | – | Device: Ellipse IM HTO NailImplant with the Ellipse IM HTO Nail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who meet the protocol eligibility criteria including standing varus malalignment in the limb presenting with osteoarthritis of the knee.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 IM HTO Nail | Device | IM HTO Nail |
Primary outcome
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)
7 secondary outcomes
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)
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)
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)
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)
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)
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)
Time to Full Weight-Bearing
Time frame: Week 2, Week 4, Week 6, Month 3, Month 6
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 Sep 2017.
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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 T Dahl, MD principal investigator
University of Minnesota
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc. at 11 sites in 4 countries.
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 7 inclusion and 16 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, United Kingdom, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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)). 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 Sep 2017.