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NCT03805490 Clinical Trial

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

Arthroplasty Clinical Trial

— FJS2015  

Official title:
Italian Validation of the Forgotten Joint Score(Fjs 2015)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03805490
Other study ID # FJS2015
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 13, 2015
Est. completion date December 15, 2019

Study information
Verified date December 2018
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date December 15, 2019
Est. primary completion date October 15, 2019
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan MI

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validating the Forgotten Joint Score. 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 BMI weight and height will be combined to calculate the BMI in kg/m^2 18 months
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