Clinical trial NCT02519218: Ellipse Intramedullary High Tibial Osteotomy Nail 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Varus Malalignment
Lead sponsor: Ellipse Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Target vs. Actual Correction
timeFrame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
measure: Target vs. Actual Correction
timeFrame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Secondary outcomes:
measure: Change in Weight-Bearing Line
timeFrame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
measure: Change in Weight-Bearing Line
timeFrame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
measure: Change in Weight-Bearing Line
timeFrame: 1-year post-operative
measure: Change in Weight-Bearing Line
timeFrame: 2-years post-operative
measure: Change in Hip-Knee-Ankle Angle
timeFrame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
measure: Change in Hip-Knee-Ankle Angle
timeFrame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
measure: Change in Hip-Knee-Ankle Angle
timeFrame: 1-year post-operative
measure: Change in Hip-Knee-Ankle Angle
timeFrame: 2-years post-operative
measure: Change in Tibial Slope
timeFrame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
measure: Change in Tibial Slope
timeFrame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
measure: Change in Tibial Slope
timeFrame: 1-year post-operative
measure: Change in Tibial Slope
timeFrame: 2 years post-operative
measure: Time to full weight-bearing
timeFrame: Participants will be followed through 2 years post-operative
measure: Bone Healing
timeFrame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
measure: Bone Healing
timeFrame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
measure: Bone Healing
timeFrame: 1-year post-operative
measure: Bone Healing
timeFrame: 2 years post-operative
Other outcomes:
measure: All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
timeFrame: Participants will be followed through 2 years post-operative
measure: All non-serious adverse events in the limb related to the device or study procedure. Study procedure includes implant procedure and correction lengthening procedure.
timeFrame: Participants will be followed through 2 years post-operative
measure: Secondary surgical procedures
timeFrame: Participants will be followed through 2 years post-operative
measure: Surgical complications
timeFrame: Participants will be followed through 2 years post-operative
Locations:
Study officials:
affiliation: University of Minnesota
name: Mark Dahl, MD
role: PRINCIPAL_INVESTIGATOR
References: