NCT03222921

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 29, 2021

Status Verified

October 1, 2020

Enrollment Period

3.6 years

First QC Date

July 17, 2017

Last Update Submit

November 17, 2021

Conditions

Tibia; Angulation

Keywords

high tibial osteotomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Full weight bearing

    12 weeks post-OP

  • Weight bearing pre- vs. post-OP

    12 weeks post-OP

  • Patient reported outcomes

    12 weeks post-OP

Interventions

High tibial osteotomyPROCEDURE

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

Also known as: pressure insole, OpenGo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing high tibial osteotomy

You may qualify if:

  • Indication for high tibial osteotomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BGU Tübingen

Tübingen, Germany

Location

Study Officials

  • Katrin Simioni, Dr.

    AO Clinical Investigation and Publishing Documentation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

March 15, 2018

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 29, 2021

Record last verified: 2020-10

Locations

DE(1)