NCT02267564

Brief Summary

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

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

10.9 years

First QC Date

September 28, 2014

Last Update Submit

June 6, 2023

Conditions

Keywords

patellar dislocationmedial patellofemoral ligamenttibial tubercle transfer

Outcome Measures

Primary Outcomes (3)

  • Lysholm score of the knee

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

    two years

  • Tegner score of the knee

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

    two years

  • Kujala score of the knee

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

    two years

Secondary Outcomes (1)

  • CT images of the knee

    two years

Study Arms (2)

MPFLR without tibial tubercle transfer

EXPERIMENTAL

Patients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer.

Procedure: MPFL reconstructionProcedure: tibial tubercle transfer

MPFLR with tibial tubercle transfer

ACTIVE COMPARATOR

Patients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer.

Procedure: MPFL reconstructionProcedure: tibial tubercle transfer

Interventions

to correct patellar dislocation with medial patellofemoral ligament reconstruction

MPFLR with tibial tubercle transferMPFLR without tibial tubercle transfer

to correct patellar dislocation with tibial tubercle medial transfer

MPFLR with tibial tubercle transferMPFLR without tibial tubercle transfer

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Officials

  • Jia-Kuo Yu, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Jia-Kuo Yu, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2014

First Posted

October 17, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations