MPFL Reconstruction With or Without Tibial Tubercle Transfer

June 6, 2023 updated by: Yu Jiakuo

Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability

This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

70 patients with recurrent patellar instability were randomly assigned to undergo MPFL reconstruction with or without tibial tubercle transfer. Follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (CT) was performed immediately after the operation and at follow-up. The knee function was evaluated preoperatively and at 2 years postoperatively using Lysholm,Tegner and Kujala scales. Redislocation or multiple episodes of patellar instability were considered failures.

Study Type

Interventional

Enrollment (Estimated)

70

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
        • Peking University Third Hospital
        • Contact:
          • Jia-Kuo Yu, Doctor
          • Phone Number: 861082267392
        • Principal Investigator:
          • Jia-Kuo Yu, Doctor
        • Sub-Investigator:
          • Hai-Jun Wang, Doctor

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

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • recurrent patellar dislocation or instability,patients with TT-TG value equal to or greater than 20 mm,patients with closed epiphyseal plate

TT-TG：Two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(TG) and the second through tibial tuberosity (TT). Distance between the lines is measured.

Exclusion Criteria:

  • bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPFLR without tibial tubercle transfer
Patients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer.
Procedure: MPFL reconstruction
to correct patellar dislocation with medial patellofemoral ligament reconstruction
Procedure: tibial tubercle transfer
to correct patellar dislocation with tibial tubercle medial transfer
Active Comparator: MPFLR with tibial tubercle transfer
Patients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer.
Procedure: MPFL reconstruction
to correct patellar dislocation with medial patellofemoral ligament reconstruction
Procedure: tibial tubercle transfer
to correct patellar dislocation with tibial tubercle medial transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm score of the knee
Time Frame: two years

Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .

Scale name:score
two years
Tegner score of the knee
Time Frame: two years

Tegner score of the knee was evaluated preoperatively and at 2 years post operation .

Scale name:score
two years
Kujala score of the knee
Time Frame: two years
Kujala score of the knee was evaluated preoperatively and at 2 years post operation .
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT images of the knee
Time Frame: two years
CT was performed immediately after the operation and at follow-up.
two years

Collaborators and Investigators

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

Sponsor

Yu Jiakuo

Investigators

  • Study Chair: Jia-Kuo Yu, Doctor, 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)

September 1, 2014

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 28, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimated)

October 17, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014099

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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