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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Varus Malalignment
• Intervention / Treatment: Device: Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System

• Study Type: Observational
• Enrollment (Actual): 6

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight-Bearing Line	Measured in percent	Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Weight-Bearing Line	Measured in percent	Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Weight-Bearing Line	Measured in percent	1-year post-operative
Change in Weight-Bearing Line	Measured in percent	2-years post-operative
Change in Hip-Knee-Ankle Angle	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	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	Measured in degrees	1-year post-operative
Change in Hip-Knee-Ankle Angle	Measured in degrees	2-years post-operative
Change in Tibial Slope	Measured in degrees	Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Tibial Slope	Measured in degrees	Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Tibial Slope	Measured in degrees	1-year post-operative
Change in Tibial Slope	Measured in degrees	2 years post-operative
Time to full weight-bearing	Measured in days	Participants will be followed through 2 years post-operative
Bone Healing	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	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	Graded 0 through 2, corresponding to Not Healing, Healing, and Healed	1-year post-operative
Bone Healing	Graded 0 through 2, corresponding to Not Healing, Healing, and Healed	2 years post-operative

Other Outcome Measures

Outcome Measure	Time Frame
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
Surgical complications	Participants will be followed through 2 years post-operative

Collaborators and Investigators

• Sponsor: Ellipse Technologies, Inc.
• Investigators: Principal Investigator: Mark Dahl, MD, University of Minnesota

Publications and helpful links

Helpful Links

• Ellipse Technologies, Inc. Website

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: PR0179