NCT04456881

Brief Summary

Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy. Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure. Expected results: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament can effectively restore the stability of the patella and the motor function of the knee joint. Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament is an effective minimally invasive technique. Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction; arthroscopy

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

January 1, 2023

Enrollment Period

4.1 years

First QC Date

June 27, 2020

Last Update Submit

April 17, 2023

Conditions

Keywords

arthroscopymedial patellofemoral ligament

Outcome Measures

Primary Outcomes (3)

  • Lysholm score

    The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.

    1 year after operation

  • International Knee Documentation Committee (IKDC) 2000

    International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.

    1 year after operation

  • Tegner activity level score

    The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.

    1 year after operation

Study Arms (1)

anatomical reconstruction group of Patellofemoral ligament

EXPERIMENTAL
Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction

Interventions

Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament

anatomical reconstruction group of Patellofemoral ligament

Eligibility Criteria

Age17 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \<age\<60 years
  • Recurrent patellar dislocation or instability

You may not qualify if:

  • \- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2020

First Posted

July 7, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations