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

NCT ID: NCT05751954

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Artroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm Label

All patients who undergo total knee arthroplasty and met inclusion and exclusion criteria

Group Type OTHER

Postero-anterior weight-bearing full-leg radiograph

Intervention Type RADIATION

Full leg standing X ray of the involved lower extremity (postero-anterior direction)

Pedobarographic analysis

Intervention Type DEVICE

Foot pressure analysis during gait on pedobarographic device

Interventions

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Postero-anterior weight-bearing full-leg radiograph

Full leg standing X ray of the involved lower extremity (postero-anterior direction)

Intervention Type RADIATION

Pedobarographic analysis

Foot pressure analysis during gait on pedobarographic device

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinic for Orthopedics Lovran

OTHER

Sponsor Role lead

Responsible Party

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Antea Buterin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinic for Orthopeadics and Traumatology Lovran

Lovran, Primorje-Gorski Kotar County, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Antea Buterin, MD

Role: CONTACT

+395911978453

Facility Contacts

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Tomislav Prpic, PhD, MD

Role: primary

+38598461143

Other Identifiers

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MEH01

Identifier Type: -

Identifier Source: org_study_id

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