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

NCT05751954 | Unknown DMC

• 1 other identifier: MEH01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Artroplasty

Keywords

weight-bearing mechanical axis; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Weight-bearing mechanical axis

  1 year

Secondary Outcomes (1)

• Pedobarographic analysis

  1 year

Study Arms (1)

Arm Label

OTHER

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

Radiation: Postero-anterior weight-bearing full-leg radiograph; Device: Pedobarographic analysis

Interventions

Postero-anterior weight-bearing full-leg radiograph RADIATION

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

Arm Label

Pedobarographic analysis DEVICE

Foot pressure analysis during gait on pedobarographic device

Arm Label

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• knee varus or valgus deformity 5 degrees or more

You may not qualify if:

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

Sponsors & Collaborators

• Clinic for Orthopedics Lovran: lead

Study Sites (1)

Clinic for Orthopeadics and Traumatology Lovran

Lovran, Primorje-Gorski Kotar County, 51145, Croatia

RECRUITING

Central Study Contacts

Antea Buterin, MD

CONTACT

+395911978453; antea.buterin@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: March 2, 2023
• Study Start: August 20, 2019
• Primary Completion: February 20, 2023
• Study Completion: December 31, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

CR (1)