OpenGo Sensor Insole in Open Wedge HTO

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03222921

Acronym

HTO

Enrollment

Registered

2017-07-19

Start date

2018-03-15

Completion date

2021-11-01

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibia; Angulation

Keywords

high tibial osteotomy

Brief 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.

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.

Interventions

PROCEDUREHigh tibial osteotomy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Indication for high tibial osteotomy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Partial weight bearing	2 weeks post-OP	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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026