Back to resultsMPFL Reconstruction With or Without Tibial Tubercle Transfer
Primary Purpose
Patellar Dislocation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MPFL reconstruction
tibial tubercle transfer
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Dislocation focused on measuring patellar dislocation, medial patellofemoral ligament, tibial tubercle transfer
Eligibility Criteria
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
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MPFLR without tibial tubercle transfer
MPFLR with tibial tubercle transfer
Arm Description
Patients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer.
Patients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer.
Outcomes
Primary Outcome Measures
Lysholm score of the knee
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Tegner score of the knee
Tegner score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Kujala score of the knee
Kujala score of the knee was evaluated preoperatively and at 2 years post operation .
Secondary Outcome Measures
CT images of the knee
CT was performed immediately after the operation and at follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02267564
Brief Title
MPFL Reconstruction With or Without Tibial Tubercle Transfer
Official Title
Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu Jiakuo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation
Keywords
patellar dislocation, medial patellofemoral ligament, tibial tubercle transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MPFLR without tibial tubercle transfer
Arm Type
Experimental
Arm Description
Patients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer.
Arm Title
MPFLR with tibial tubercle transfer
Arm Type
Active Comparator
Arm Description
Patients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer.
Intervention Type
Procedure
Intervention Name(s)
MPFL reconstruction
Intervention Description
to correct patellar dislocation with medial patellofemoral ligament reconstruction
Intervention Type
Procedure
Intervention Name(s)
tibial tubercle transfer
Intervention Description
to correct patellar dislocation with tibial tubercle medial transfer
Primary Outcome Measure Information:
Title
Lysholm score of the knee
Description
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Time Frame
two years
Title
Tegner score of the knee
Description
Tegner score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Time Frame
two years
Title
Kujala score of the knee
Description
Kujala score of the knee was evaluated preoperatively and at 2 years post operation .
Time Frame
two years
Secondary Outcome Measure Information:
Title
CT images of the knee
Description
CT was performed immediately after the operation and at follow-up.
Time Frame
two years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia-Kuo Yu, Doctor
Phone
861082267392
Email
yujiakuo@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Kuo Yu, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia-Kuo Yu, Doctor
Phone
861082267392
First Name & Middle Initial & Last Name & Degree
Jia-Kuo Yu, Doctor
First Name & Middle Initial & Last Name & Degree
Hai-Jun Wang, Doctor
12. IPD Sharing Statement
Learn more about this trial
MPFL Reconstruction With or Without Tibial Tubercle Transfer
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