- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267564
MPFL Reconstruction With or Without Tibial Tubercle Transfer
Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jia-Kuo Yu, Doctor
- Phone Number: 861082267392
- Email: yujiakuo@126.com
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
to correct patellar dislocation with medial patellofemoral ligament reconstruction
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.
|
to correct patellar dislocation with medial patellofemoral ligament reconstruction
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
Sponsor
Investigators
- Study Chair: Jia-Kuo Yu, Doctor, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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