OpenGo Sensor Insole in Open Wedge HTO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-15

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Tibia; Angulation

Keywords

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high tibial osteotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High tibial osteotomy

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

Intervention Type PROCEDURE

Other Intervention Names

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pressure insole, OpenGo

Eligibility Criteria

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Inclusion Criteria

* Indication for high tibial osteotomy

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrin Simioni, Dr.

Role: STUDY_DIRECTOR

AO Clinical Investigation and Publishing Documentation

Locations

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BGU Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HTO Moticon

Identifier Type: -

Identifier Source: org_study_id