The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation

Treatment Clinical Trial

Official title:

The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243134
• Other study ID #: IRB00006761-M2021423
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Anatomic Abnormality
• Athletic Injuries
• Congenital Abnormalities
• Femoral Anteversion
• Patellar Dislocation
• Sport Injury
• Treatment

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