NCT03805490

Unknown

Translation, Cross Cultural Adaptation and Validation of the...

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

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Other study identifiers

Sponsor study identifier

FJS2015

Study Type

observational

Estimated enrollment

120

Locations

1 country

Sites

1

Timeline

Study Start

May 13, 2015

Actual (reported)

Primary Completion

October 15, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 15, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 120 participants
Study completion date: December 15, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 13, 2015
Actual (reported)
First Submitted
November 28, 2017
Actual (reported)
First Posted
January 15, 2019
Actual (reported)
Primary Completion
October 15, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 15, 2019
Status Verified: December 2018
Last Update Submitted: January 14, 2019

Conditions

Arthroplasty Surveys and Questionnaires

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

BMI
18 months

Eligibility Criteria

Age55 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

Males and females

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

Related Publications (1)

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.
PMID: 31926561DERIVED

Study Officials

Valerio Pascale
IRCCS Istituto Ortopedico Galeazzi
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

January 15, 2019

Study Start

May 13, 2015

Actual (reported)

Primary Completion

October 15, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Not Applicable

Completed

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Phase 4Recruiting

Age range between 55 and 85 years

Italian mother-tongue

Patients with unilateral gonarthrosis who need total knee prosthesis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Completion

December 15, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 15, 2019

Record last verified: 2018-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03805490
Data provider: ClinicalTrials.gov
Source updated: 2019-01-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:33 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations