NCT05243134

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 16, 2022

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

November 23, 2021

Last Update Submit

February 7, 2022

Conditions

Keywords

Patellar dislocationAnatomic deformitytrochlear dysplasiatreatment

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Skeletal force line and various angles by X-ray evaluation

    Preoperative

Study Arms (2)

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

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

Control groupStudy Group

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with patellar dislocation

You may qualify if:

  • Patients with patellar dislocation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patellar DislocationCongenital Abnormalities

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg InjuriesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lin Lin

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Lin Lin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

February 16, 2022

Study Start

September 30, 2021

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

February 16, 2022

Record last verified: 2021-09

Locations