OpenGo Sensor Insole in Open Wedge HTO (HTO)

Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be studied during 12 weeks for their post-operative weight bearing using a pressure insole.

Study Overview

• Status: Terminated
• Conditions: Tibia; Angulation
• Intervention / Treatment: Procedure: High tibial osteotomy

Detailed Description

Forty patients who are planned for open wedge HTO with deformity in the proximal tibia will be included in the study. The open wedge HTO will be performed in the well known biplanar technique and the TomoFix plate will be used as fixation plate. To analyze the peak pressure and if the patients are able to reassemble the partial weight bearing/ the full weight bearing the OpenGo Sensor Insole (Moticon) will be used during the first 12 weeks after surgery. In addition, x-rays will be analyze for the alignment and angles and clinical scores will be gathered to investigate patient reported outcomes.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany
    • BGU Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing high tibial osteotomy

Description

Inclusion Criteria:

• Indication for high tibial osteotomy

Exclusion Criteria:

• Impairment of the shoulder which has an influence on the ability for partial weight bearing

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial weight bearing	Differences of the peak pressure (mean of the 13 pressure sensors) recorded by the insole vs. the recommended partial weight bearing of 20 kg and amount of events more than 20 kg partial weight bearing	2 weeks post-OP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full weight bearing	Time to full weight bearing after open wedge HTO	12 weeks post-OP
Weight bearing pre- vs. post-OP	Changes of peak pressure at the sole comparing varus deformity and after open wedge HTO	12 weeks post-OP
Patient reported outcomes	Depends the clinical outcome on the capability of early full-weight bearing?	12 weeks post-OP

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Collaborators: Berufsgenossenschaftlichen Unfallklinik Tuebingen
• Investigators: Study Director: Katrin Simioni, Dr., AO Clinical Investigation and Publishing Documentation

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: high tibial osteotomy
• Other Study ID Numbers: HTO Moticon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No