Medial Patellofemoral DislocationNCT06009822
Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction
An observational study of Medial Patellofemoral Dislocation and Kinesiophobia, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Patellofemoral Dislocation, Kinesiophobia
- What is being tested?
- Postoperative outcome measurements
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to Oct 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent unilateral MPFL reconstruction in the Department of Orthopedics and Traumatology, Gazi University Hospital between 2004 and 2019
Who may be able to join
- Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction
- At least 2 years after the operation
Who cannot join
- Patellar instability
- Knee ligament injury
- Meniscus injury
- Knee osteoarthritis
- Ankle ligament injury
- Ankle osteoarthritis
- Any neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Zeynep Hazar, PhD
About this study
Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.
- Conditions
- Medial Patellofemoral Dislocation, Kinesiophobia
- Being tested
- Postoperative outcome measurements
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative outcome measurementsOther
Kinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated.
Biodex Bio-balance system device will be used for single leg sway index.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Medial Patellofemoral Ligament reconstruction | Must have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction.
At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction. Receives: Other: Postoperative outcome measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.
Measured: up to 3 months
Secondary outcomes (5)
Knee Score
Function will be measured by the Lysholm knee score.The total score on the Lysholm Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:
95-100: Excellent knee function 84-94: Good knee function 65-83: Fair knee function Below 65: Poor knee function
Measured: up to 3 months
Patellofemoral Knee Score
Function will be measured by the Kujala Patellofemoral Knee Score. The total score on the Kujala Patellofemoral Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:
100: No limitations or symptoms 85-99: Mild limitations or symptoms 70-84: Moderate limitations or symptoms Below 70: Severe limitations or symptoms
Measured: up to 3 months
Single-leg hop test
The single-leg hop distance is an indicator of lower extremity function. The test evaluates an individual's lower limb strength, power, and overall functional performance. It specifically focuses on assessing an individual's ability to generate power and stability while performing a single-leg hop for maximal distance. When performing the test, the individual starts by standing on one leg at the starting point. The opposite leg is lifted slightly off the ground, and the hands can be placed on the hips or kept at the sides for balance. On the command to start, the individual hops forward on the single leg, aiming to jump as far as possible while maintaining control and balance. Perform 3 repetitions and record the longest distance jumped.
Measured: up to 3 months
Dynamic balance
Dynamic balance will be measured by Y Balance Test. The Y Balance Test involves a person standing on one leg while reaching in anterior (forward), posteromedial (backward and to the side), and posterolateral (backward and to the other side) directions with the other leg. The person places their stance foot at the starting point on the central part of the Y-shaped device.While maintaining balance on the stance leg, the person reaches the free leg as far as possible along each of the three arms of the Y.The distance reached in each direction is measured and recorded.
Measured: up to 3 months
Static balance
Static balance will be measured using a Biodex Balance System, single leg sway index test procedure. The device reports the person's body oscillations as sway index. A high stability index indicates poor postural control.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Patellofemoral DislocationStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Zeynep Hazar, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009822
- Sponsor's protocol ID
- Iayas4
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction
- ClinicalTrials.gov ID
- NCT06009822
- Acronym / sponsor ID
- Iayas4
- Conditions
- Medial Patellofemoral Dislocation, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Aug 2023 (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.
Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Medial Patellofemoral Ligament reconstruction | – | Other: Postoperative outcome measurementsMust have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction. At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent unilateral MPFL reconstruction in the Department of Orthopedics and Traumatology, Gazi University Hospital between 2004 and 2019
Key inclusion criteria (2 listed)
- Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction
- At least 2 years after the operation
Key exclusion criteria (7 listed)
- Patellar instability
- Knee ligament injury
- Meniscus injury
- Knee osteoarthritis
- Ankle ligament injury
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 |
|---|---|---|
| Postoperative outcome measurementsKinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated. Biodex Bio-balance system device will be used for single leg sway index. | Other | Patients with Medial Patellofemoral Ligament reconstruction |
Primary outcome
Kinesiophobia
Time frame: up to 3 months
Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.
5 secondary outcomes
Knee Score
Time frame: up to 3 months
Patellofemoral Knee Score
Time frame: up to 3 months
Single-leg hop test
Time frame: up to 3 months
Dynamic balance
Time frame: up to 3 months
Static balance
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
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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.
Zeynep Hazar study director
Gazi University
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 Medial Patellofemoral Dislocation and Kinesiophobia, run by Gazi University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 24 Aug 2023. 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 Turkey (Türkiye). 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?
Contact İnci H Ayas, Msc (+90 0312 216 26 01, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: up to 3 months). 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 24 Aug 2023.