Clinical Trials Directory

Trials / Terminated

TerminatedNCT03222921

OpenGo Sensor Insole in Open Wedge HTO

Status
Terminated
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
AO Innovation Translation Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2018-03-15
Primary completion
2021-11-01
Completion
2021-11-01
First posted
2017-07-19
Last updated
2021-11-29

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03222921. Inclusion in this directory is not an endorsement.