Ellipse Intramedullary High Tibial Osteotomy Nail Study

Completed

• Conditions: Osteoarthritis; Varus Malalignment

• Registration Number: NCT02519218
• Lead Sponsor: Ellipse Technologies, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-10
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vs. Actual Correction	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)

Secondary Outcome Measures

Name	Time	Method
Change in Weight-Bearing Line	2-years post-operative	Measured in percent
Change in Hip-Knee-Ankle Angle	2-years post-operative	Measured in degrees
Change in Tibial Slope	2 years post-operative	Measured in degrees
Time to full weight-bearing	Participants will be followed through 2 years post-operative	Measured in days
Bone Healing	2 years post-operative	Graded 0 through 2, corresponding to Not Healing, Healing, and Healed