Overview

This trial is active, not recruiting.

Conditions osteoarthritis, varus malalignment
Treatment ellipse technologies intramedullary high tibial osteotomy nail system
Sponsor Ellipse Technologies, Inc.
Start date August 2015
End date October 2015
Trial size 6 participants
Trial identifier NCT02519218, PR0179

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Measure
Target vs. Actual Correction
time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Target vs. Actual Correction
time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

Secondary Outcomes

Measure
Change in Weight-Bearing Line
time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Weight-Bearing Line
time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Weight-Bearing Line
time frame: 1-year post-operative
Change in Weight-Bearing Line
time frame: 2-years post-operative
Change in Hip-Knee-Ankle Angle
time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Hip-Knee-Ankle Angle
time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Hip-Knee-Ankle Angle
time frame: 1-year post-operative
Change in Hip-Knee-Ankle Angle
time frame: 2-years post-operative
Change in Tibial Slope
time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Change in Tibial Slope
time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Change in Tibial Slope
time frame: 1-year post-operative
Change in Tibial Slope
time frame: 2 years post-operative
Time to full weight-bearing
time frame: Participants will be followed through 2 years post-operative
Bone Healing
time frame: Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Bone Healing
time frame: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Bone Healing
time frame: 1-year post-operative
Bone Healing
time frame: 2 years post-operative

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

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
Principal investigator Mark Dahl, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Ellipse Technologies, Inc..