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

NCT ID: NCT03805490

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-13

Study Completion Date

2019-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Arthroplasty Surveys and Questionnaires

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerio Pascale

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, MI, Italy

Site Status

Countries

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Italy

References

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Sansone V, Fennema P, Applefield RC, Marchina S, Ronco R, Pascale W, Pascale V. Translation, cross-cultural adaptation, and validation of the Italian language Forgotten Joint Score-12 (FJS-12) as an outcome measure for total knee arthroplasty in an Italian population. BMC Musculoskelet Disord. 2020 Jan 11;21(1):23. doi: 10.1186/s12891-019-2985-2.

Reference Type DERIVED
PMID: 31926561 (View on PubMed)

Other Identifiers

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FJS2015

Identifier Type: -

Identifier Source: org_study_id

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