NCT02906735

Brief Summary

Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 8, 2016

Last Update Submit

October 18, 2016

Conditions

Knee Pain Treated With Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Foot pressure curve preoperatively

    scale

    -1 day

Secondary Outcomes (1)

  • Foot pressure curve postoperatively

    1 year

Study Arms (1)

Study group

Patients with knee surgery undergo plantar foot pressure measurement pre- and postoperatively

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Implantation of knee joint prosthesis or deviation osteotomies of the knee

Study group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients planned for knee surgery

You may qualify if:

  • Patients planned for knee surgery willing to participate at this study

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Norbert Harrasser

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Norbert Harrasser

CONTACT

15232716657norbert.harrasser@gmx.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-09

Locations

DE(1)