Ellipse Intramedullary High Tibial Osteotomy Nail Study

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519218
• Other study ID #: PR0179
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: January 30, 2018
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Varus Malalignment

Intervention

Device:
• Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)		Participants will be followed through 2 years post-operative
Other	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
Other	Secondary surgical procedures		Participants will be followed through 2 years post-operative
Other	Surgical complications		Participants will be followed through 2 years post-operative
Primary	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
Primary	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	Change in Weight-Bearing Line	Measured in percent	Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Secondary	Change in Weight-Bearing Line	Measured in percent	Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Secondary	Change in Weight-Bearing Line	Measured in percent	1-year post-operative
Secondary	Change in Weight-Bearing Line	Measured in percent	2-years post-operative
Secondary	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
Secondary	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
Secondary	Change in Hip-Knee-Ankle Angle	Measured in degrees	1-year post-operative
Secondary	Change in Hip-Knee-Ankle Angle	Measured in degrees	2-years post-operative
Secondary	Change in Tibial Slope	Measured in degrees	Participants will be followed for the duration of correcting their deformity, an average of 3 weeks
Secondary	Change in Tibial Slope	Measured in degrees	Participants will be followed for the duration of consolidation (bone healing), an average of 4 months
Secondary	Change in Tibial Slope	Measured in degrees	1-year post-operative
Secondary	Change in Tibial Slope	Measured in degrees	2 years post-operative
Secondary	Time to full weight-bearing	Measured in days	Participants will be followed through 2 years post-operative
Secondary	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
Secondary	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
Secondary	Bone Healing	Graded 0 through 2, corresponding to Not Healing, Healing, and Healed	1-year post-operative
Secondary	Bone Healing	Graded 0 through 2, corresponding to Not Healing, Healing, and Healed	2 years post-operative

External Links

•   Ellipse Technologies, Inc. website