Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty

February 20, 2023 updated by: Antea Buterin, Clinic for Orthopedics Lovran
This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. In addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. The practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). Our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (AOFAS, KOOS) preoperatively, and at the screening three months postoperatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
    • Primorsko-Goranska
      • Lovran, Primorsko-Goranska, Croatia, 51145
        • Recruiting
        • Clinic for Orthopeadics and Traumatology Lovran
        • Contact:
        • Principal Investigator:
          • Antea Buterin, MD
        • Principal Investigator:
          • Sandra Spanja Prpic, mag.physiotherap.
        • Principal Investigator:
          • Mirela Vuckovic, mag.physiotherap.
        • Principal Investigator:
          • Tomislav Prpic, PhD, MD, Assist. Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee varus or valgus deformity 5 degrees or more

Exclusion Criteria:

  • previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm Label
All patients who undergo total knee arthroplasty and met inclusion and exclusion criteria
Radiation: Postero-anterior weight-bearing full-leg radiograph
Full leg standing X ray of the involved lower extremity (postero-anterior direction)
Device: Pedobarographic analysis
Foot pressure analysis during gait on pedobarographic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight-bearing mechanical axis
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pedobarographic analysis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinic for Orthopedics Lovran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Anticipated)

February 20, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 31, 2019

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEH01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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