Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty (FJS2015)

January 14, 2019 updated by: Istituto Ortopedico Galeazzi

Italian Validation of the Forgotten Joint Score(Fjs 2015)

This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS)

Study Overview

Status

Unknown

Conditions

Detailed Description

This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.

Comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (WOMAC).

Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

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

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of both gender, aged between 55 and 85 years old, Italian mother-tongue with unilateral gonarthrosis who need total knee prosthesis

Description

Inclusion Criteria:

  • Males and females
  • Age range between 55 and 85 years
  • Italian mother-tongue
  • Patients with unilateral gonarthrosis who need total knee prosthesis

Exclusion Criteria:

  • Patients with orthopedic pathologies of other origin
  • Patients with history of previous articular prosthetic replacement surgery on joints of the lower limb.
  • Patients with history of previous major cardiovascular events
  • Patients who need aids for walking
  • Patients claiming that they can not submit to follow-up and therefore can not complete the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validating the Forgotten Joint Score.
Time Frame: 18 month

Patients will be given self-assessment questionnaires Forgotten Joint Score (FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.

FJS: minimum score 0 (worse outcome); maximum 100 (better outcome)
18 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 18 months
weight and height will be combined to calculate the BMI in kg/m^2
18 months

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Valerio Pascale, IRCCS Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 13, 2015

Primary Completion (ANTICIPATED)

October 15, 2019

Study Completion (ANTICIPATED)

December 15, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

January 14, 2019

First Posted (ACTUAL)

January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FJS2015

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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