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

• Conditions: Arthroplasty; Surveys and Questionnaires

• Registration Number: NCT03805490
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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

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 Timeline

• Study Start: 2015-05-13
• Study First Submitted: 2017-11-28
• Status Verified: 2018-12
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-10-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validating the Forgotten Joint Score.	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)

Secondary Outcome Measures

Name	Time	Method
BMI	18 months	weight and height will be combined to calculate the BMI in kg/m\^2

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, MI, Italy