Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament

April 17, 2023 updated by: Peking University Third Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
        • Contact:
          • Ping Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anatomical reconstruction group of Patellofemoral ligament
Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction
Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm score
Time Frame: 1 year after operation
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
Time Frame: 1 year after operation
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
1 year after operation
Tegner activity level score
Time Frame: 1 year after operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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