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

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 Overview

• Status: Recruiting
• Conditions: Patellar Dislocation; Treatment; Sport Injury; Anatomic Abnormality; Trochlear Dysplasia; Femoral Anteversion
• Intervention / Treatment: Other: Collect the clinical data

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jia_kuo Yu; Phone Number: 01082267392; Email: yujiakuo@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Institute of Sports Medicine, Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with patellar dislocation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Patients with at least one type of anatomic deformity	Other: Collect the clinical data; We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.
Control group; Patients without anatomic deformity	Other: Collect the clinical data; We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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).	Three years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Publications and helpful links

General 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. 2022 Sep 11. doi: 10.1007/s00167-022-07119-8. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2021
• Primary Completion (ANTICIPATED): December 30, 2025
• Study Completion (ANTICIPATED): December 30, 2025

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (ACTUAL): February 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: treatment; Patellar dislocation; Anatomic deformity; trochlear dysplasia
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Congenital Abnormalities; Joint Dislocations; Patellar Dislocation; Athletic Injuries
• Other Study ID Numbers: IRB00006761-M2021423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No