Patello Femoral SyndromeNCT05112978
Evaluation of Patellar Dimension and Bristol Index in Asian Population
An observational study of Patello Femoral Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. Read more about this study
- Who is it for?
- Ages 17 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patello Femoral Syndrome
- What is being tested?
- MRI
- How many people
- 101 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2019to 31 Jan 2021
- 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 17 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: all patients came to clinic
Who may be able to join
- knee pain
Who cannot join
- degenerative joint disease
- patellofemoral pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patellar Dimension and Bristol Index in Asian Population: an MRI Study
Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. This study aims to evaluate the patellar dimension and Bristol Index of patellar width to thickness (BIPWiT) using magnetic resonance imaging (MRI) in Asian population.
- Conditions
- Patello Femoral Syndrome
- Being tested
- MRI
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI genu non contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
bristol index
Measured: 1 day MRI examination
Secondary outcomes (1)
patellar sizes
Measured: 1 day MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patello Femoral SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112978
- Sponsor's protocol ID
- BRIS
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patellar Dimension and Bristol Index in Asian Population: an MRI Study
- ClinicalTrials.gov ID
- NCT05112978
- Acronym / sponsor ID
- BRIS
- Conditions
- Patello Femoral Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Nov 2021 (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.
Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. This study aims to evaluate the patellar dimension and Bristol Index of patellar width to thickness (BIPWiT) using magnetic resonance imaging (MRI) in Asian population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- all patients came to clinic
Key inclusion criteria (1 listed)
- knee pain
Key exclusion criteria (2 listed)
- degenerative joint disease
- patellofemoral pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI genu non contrast | Diagnostic test | – |
Primary outcome
bristol index
Time frame: 1 day MRI examination
1 secondary outcome
patellar sizes
Time frame: 1 day MRI examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patello Femoral Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 2021. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bristol index (time frame: 1 day MRI examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2021.