OpenGo Sensor Insole in Open Wedge HTO
- Conditions
- Tibia; Angulation
- Registration Number
- NCT03222921
- Lead Sponsor
- AO Innovation Translation Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
- Indication for high tibial osteotomy
- Impairment of the shoulder which has an influence on the ability for partial weight bearing
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patient reported outcomes 12 weeks post-OP Depends the clinical outcome on the capability of early full-weight bearing?
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
Full weight bearing 12 weeks post-OP Time to full weight bearing after open wedge HTO
Trial Locations
- Locations (1)
BGU Tübingen
🇩🇪Tübingen, Germany