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

Sponsor

Clinic for Orthopedics Lovran (Other)

Overall Status

Recruiting

CT.gov ID

NCT05751954

Collaborator

(none)

100

Enrollment

Location

Arm

64.4

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Artroplasty	Radiation: Postero-anterior weight-bearing full-leg radiograph Device: Pedobarographic analysis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Feb 20, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Weight-bearing mechanical axis [1 year]

Secondary Outcome Measures

Pedobarographic analysis [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Orthopeadics and Traumatology Lovran	Lovran	Primorsko-Goranska	Croatia	51145

Sponsors and Collaborators

Clinic for Orthopedics Lovran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antea Buterin, MD, Clinic for Orthopedics Lovran

ClinicalTrials.gov Identifier:

NCT05751954

Other Study ID Numbers:

MEH01

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antea Buterin, MD, Clinic for Orthopedics Lovran

weight-bearing mechanical axis

total knee arthroplasty

Study Results

No Results Posted as of Mar 2, 2023