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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05243134
Other study ID # IRB00006761-M2021423
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date December 30, 2025

Study information

Verified date September 2021
Source Peking University Third Hospital
Contact Jia_kuo Yu
Phone 01082267392
Email yujiakuo@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 40 Years
Eligibility Inclusion Criteria: -Patients with patellar dislocation. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Collect the clinical data
We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.

Locations

Country Name City State
China Institute of Sports Medicine, Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Three years after surgery
Primary 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. Three years after surgery
Primary 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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3). Three years after surgery
Secondary 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. Preoperative
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