Ellipse Intramedullary High Tibial Osteotomy Nail Study
Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System
1 other identifier
observational
6
0 countries
N/A
Brief Summary
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 1, 2018
January 1, 2018
2.2 years
August 5, 2015
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Target vs. Actual Correction
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
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 Outcomes (17)
Change in Weight-Bearing Line
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Weight-Bearing Line
Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Weight-Bearing Line
1-year post-operative
Change in Weight-Bearing Line
2-years post-operative
Change in Hip-Knee-Ankle Angle
Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
- +12 more secondary outcomes
Other Outcomes (4)
All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
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.
Participants will be followed through 2 years post-operative
Secondary surgical procedures
Participants will be followed through 2 years post-operative
- +1 more other outcomes
Interventions
Eligibility Criteria
Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.
You may qualify if:
- 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.
You may not qualify if:
- Patient is currently enrolled in another clinical trial for high tibial osteotomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Dahl, MD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 10, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01