OpenGo Sensor Insole in Open Wedge HTO

Tibia; Angulation Clinical Trial

— HTO  

Official title:

OpenGo Sensor Insole in Open Wedge HTO

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03222921
• Other study ID #: HTO Moticon
• Status: Terminated
• Start date: March 15, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: October 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for high tibial osteotomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Tibia; Angulation

Intervention

Procedure:
• High tibial osteotomy
Patients undergoing high tibial osteotomy are investigated by a pressure insole for post-operative weight bearing behavior

Locations

Country	Name	City	State
Germany	BGU Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
AO Innovation Translation Center	Berufsgenossenschaftlichen Unfallklinik Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Full weight bearing	Time to full weight bearing after open wedge HTO	12 weeks post-OP
Secondary	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
Secondary	Patient reported outcomes	Depends the clinical outcome on the capability of early full-weight bearing?	12 weeks post-OP