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RecruitingNCT05243134Updated Feb 16, 2022

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

An observational study in Patellar Dislocation, Anatomic Abnormality and Trochlear Dysplasia, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 14 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
14 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Patellar Dislocation
  • Anatomic Abnormality
  • Trochlear Dysplasia
  • Femoral Anteversion
  • Treatment
  • Sport Injury

Keywords

  • Patellar dislocation
  • Anatomic deformity
  • trochlear dysplasia
  • treatment
03

Who can participate

Ages eligible
14 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with patellar dislocation

Inclusion criteria

-Patients with patellar dislocation.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Study Group

    Patients with at least one type of anatomic deformity

    Other: Collect the clinical data

  • Control group

    Patients without anatomic deformity

    Other: Collect the clinical data

Interventions

  • OtherCollect the clinical data

    We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three years after surgery

  2. 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.

    Time frame: Three years after surgery

  3. 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).

    Time frame: 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.

    Time frame: Preoperative

06

Study locations

1 of 1 sites recruiting
  • Institute of Sports Medicine, Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT05243134
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Feb 16, 2022
Start date
Sep 30, 2021
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Feb 16, 2022

Study contacts

Jia_kuo Yu
Contact
yujiakuo@126.com
01082267392
Lin Lin
Contact
01082267392
Lin Lin
study director · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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