Patellar DislocationNCT05243134
The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
An observational study of Patellar Dislocation and Anatomic Abnormality, run by Peking University Third Hospital at 1 site in China.
Trial summary
All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Patellar Dislocation, Anatomic Abnormality, Trochlear Dysplasia
- What is being tested?
- Collect the clinical data
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to 30 Dec 2025
- How long will I take part?
- 5 Years
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with patellar dislocation
Who may be able to join
- -Patients with patellar dislocation.
Who cannot join
- Patients with significant ligamentous knee injury.
- Previous fracture or surgery of the lower limb.
- Patellar dislocation caused by car accidents or other high-energy force directly on the patella.
Trial locations and contacts
1 site in 1 country.
Lin Lin contact
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-kuo Yu, MD, 86-10-82267392, yujiakuo@126.com
About this study
All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.
- Conditions
- Patellar Dislocation, Anatomic Abnormality, Trochlear Dysplasia, Femoral Anteversion, Treatment, Sport Injury
- Being tested
- Collect the clinical data
- Keywords
- Patellar dislocation, Anatomic deformity, trochlear dysplasia, treatment
- Medical subject headings
- Patellar Dislocation, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect the clinical dataOther
We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with at least one type of anatomic deformity Receives: Other: Collect the clinical data | |
| Control group | Patients without anatomic deformity Receives: Other: Collect the clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination
We can determine patellar redislocation by physical examination. In participants with redislocation of their patella, the patella (kneecap) slips out of its normal position. Often the knee is partly bent, painful and swollen.The patella is also often felt and seen out of place. We recored the number of participants with redislocation of their patella after surgery.
Measured: Three years after surgery
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: Three years after surgery
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: Three years after surgery
Secondary outcomes (1)
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start30 Sep 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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 Patellar DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Lin, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243134
- Sponsor's protocol ID
- IRB00006761-M2021423
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Z, Song Y, Deng R, Ye J, Wang X, Wang H, Yu JK. CT and MRI measurements of tibial tubercle lateralization in patients with patellar dislocation were not equivalent but could be interchangeable. Knee Surg Sports Traumatol Arthrosc. 2023 Jan;31(1):349-357. doi: 10.1007/s00167-022-07119-8. Epub 2022 Sep 11.
PubMed 36088618
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
- ClinicalTrials.gov ID
- NCT05243134
- Acronym / sponsor ID
- IRB00006761-M2021423
- Conditions
- Patellar Dislocation, Anatomic Abnormality, Trochlear Dysplasia, Femoral Anteversion, Treatment, Sport Injury
- Keywords
- Patellar dislocation, Anatomic deformity, trochlear dysplasia, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Feb 2022 (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.
All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Collect the clinical dataPatients with at least one type of anatomic deformity |
| Control group | – | Other: Collect the clinical dataPatients without anatomic deformity |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with patellar dislocation
Key inclusion criteria (1 listed)
- -Patients with patellar dislocation.
Key exclusion criteria (3 listed)
- Patients with significant ligamentous knee injury.
- Previous fracture or surgery of the lower limb.
- Patellar dislocation caused by car accidents or other high-energy force directly on the patella.
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 |
|---|---|---|
| Collect the clinical dataWe analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up. | Other | Control group, Study Group |
Primary outcome
Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination
Time frame: Three years after surgery
We can determine patellar redislocation by physical examination. In participants with redislocation of their patella, the patella (kneecap) slips out of its normal position. Often the knee is partly bent, painful and swollen.The patella is also often felt and seen out of place. We recored the number of participants with redislocation of their patella after surgery.
International Knee Documentation Committee(IKDC) score
Time frame: Three years after surgery
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Magnatic Resonance Imaging evaluation
Time frame: Three years after surgery
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
1 secondary outcome
Skeletal force line and various angles by X-ray evaluation
Time frame: Preoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 36088618Xu Z, Song Y, Deng R, Ye J, Wang X, Wang H, Yu JK. CT and MRI measurements of tibial tubercle lateralization in patients with patellar dislocation were not equivalent but could be interchangeable. Knee Surg Sports Traumatol Arthrosc. 2023 Jan;31(1):349-357. doi: 10.1007/s00167-022-07119-8. Epub 2022 Sep 11.
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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.
Lin Lin contact
Lin Lin study director
Peking University Third Hospital
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 Patellar Dislocation and Anatomic Abnormality, run by Peking University Third Hospital at 1 site in China.
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 3 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 16 Feb 2022. 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 China. 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 Jia_kuo Yu (01082267392, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination (time frame: Three years after surgery). The study lists 3 primary outcomes in all. 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 NCT05243134, 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 16 Feb 2022.