ArthroplastyFJS2015NCT03805490
Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty
An observational study of Arthroplasty and Surveys and Questionnaires, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Arthroplasty, Surveys and Questionnaires
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2015to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both gender, aged between 55 and 85 years old, Italian mother-tongue with unilateral gonarthrosis who need total knee prosthesis
Who may be able to join
- Males and females
- Age range between 55 and 85 years
- Italian mother-tongue
- Patients with unilateral gonarthrosis who need total knee prosthesis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Arthroplasty, Surveys and Questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 month
Secondary outcomes (1)
BMI
weight and height will be combined to calculate the BMI in kg/m^2
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start13 May 2015
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerio Pascale, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805490
- Sponsor's protocol ID
- FJS2015
- Acronym
- FJS2015
- Status last verified
- Dec 2018
- First submitted
- 28 Nov 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31926561
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation of the Forgotten Joint Score(Fjs 2015)
- ClinicalTrials.gov ID
- NCT03805490
- Acronym / sponsor ID
- FJS2015 / FJS2015
- Conditions
- Arthroplasty, Surveys and Questionnaires
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 13 May 2015 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both gender, aged between 55 and 85 years old, Italian mother-tongue with unilateral gonarthrosis who need total knee prosthesis
Key inclusion criteria (4 listed)
- Males and females
- Age range between 55 and 85 years
- Italian mother-tongue
- Patients with unilateral gonarthrosis who need total knee prosthesis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
BMI
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 31926561Sansone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerio Pascale principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Surveys and Questionnaires, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validating the Forgotten Joint Score. (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.