Back to resultsArthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
Primary Purpose
Recurrent Patellar Dislocation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Patients with patellar dislocation undergo patellar femoral medial reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Patellar Dislocation focused on measuring arthroscopy, medial patellofemoral ligament
Eligibility Criteria
Inclusion Criteria:
- 17<age<60 years
- Recurrent patellar dislocation or instability
Exclusion Criteria:
- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.
Sites / Locations
- Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, ChinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anatomical reconstruction group of Patellofemoral ligament
Arm Description
Outcomes
Primary Outcome Measures
Lysholm score
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
International Knee Documentation Committee (IKDC) 2000
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Tegner activity level score
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT04456881
First Posted
June 27, 2020
Last Updated
April 17, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04456881
Brief Title
Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
Official Title
Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy.
Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Expected results: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament can effectively restore the stability of the patella and the motor function of the knee joint.
Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament is an effective minimally invasive technique.
Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction; arthroscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Patellar Dislocation
Keywords
arthroscopy, medial patellofemoral ligament
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anatomical reconstruction group of Patellofemoral ligament
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patients with patellar dislocation undergo patellar femoral medial reconstruction
Intervention Description
Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament
Primary Outcome Measure Information:
Title
Lysholm score
Description
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
Time Frame
1 year after operation
Title
International Knee Documentation Committee (IKDC) 2000
Description
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Time Frame
1 year after operation
Title
Tegner activity level score
Description
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Time Frame
1 year after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
17<age<60 years
Recurrent patellar dislocation or instability
Exclusion Criteria:
- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Liu
Phone
13683670396
Email
bjusmlp@126.com
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Liu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
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