MPFL Reconstruction With or Without Tibial Tubercle Transfer

NCT ID: NCT02267564

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2025-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patellar Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MPFLR without tibial tubercle transfer

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

Group Type EXPERIMENTAL

MPFL reconstruction

Intervention Type PROCEDURE

to correct patellar dislocation with medial patellofemoral ligament reconstruction

tibial tubercle transfer

Intervention Type PROCEDURE

to correct patellar dislocation with tibial tubercle medial transfer

MPFLR with tibial tubercle transfer

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

Group Type ACTIVE_COMPARATOR

MPFL reconstruction

Intervention Type PROCEDURE

to correct patellar dislocation with medial patellofemoral ligament reconstruction

tibial tubercle transfer

Intervention Type PROCEDURE

to correct patellar dislocation with tibial tubercle medial transfer

Interventions

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MPFL reconstruction

to correct patellar dislocation with medial patellofemoral ligament reconstruction

Intervention Type PROCEDURE

tibial tubercle transfer

to correct patellar dislocation with tibial tubercle medial transfer

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yu Jiakuo

OTHER

Sponsor Role lead

Responsible Party

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Yu Jiakuo

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jia-Kuo Yu, Doctor

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia-Kuo Yu, Doctor

Role: CONTACT

861082267392

Facility Contacts

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Jia-Kuo Yu, Doctor

Role: primary

861082267392

Other Identifiers

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2014099

Identifier Type: -

Identifier Source: org_study_id

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