- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461431
Clinical Study of Posterolateral Structure of Knee Joint Under Arthroscopy
Clinical Study of Anatomical Reconstruction Technique of Posterolateral Structure of Knee Joint Under Arthroscopy
Objective: To study the clinical effect of anatomical reconstruction of the posterolateral structure of the knee joint under arthroscopy.
Methods: The patients who were admitted to hospital for the treatment of posterolateral structural injuries of the knee joint, including those with other ligament injuries (combined with anterior and posterior cruciate ligament injuries and medial collateral ligament injuries) were subjected to arthroscopic reconstruction of the posterolateral structures. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Expected results: The anatomical reconstruction technique of the posterolateral structure of the knee joint under arthroscopy may effectively restore the stability and motor function of the knee joint.
Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee is an effective minimally invasive technique.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ping Liu
- Phone Number: 13683670396
- Email: bjusm@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China
-
Contact:
- Ping Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age <70 years old
- Those without avulsion of the affected biceps femoris tendon or iliac tibial bundle
- Those without avulsion fracture of the fibular stop of the lateral collateral ligament
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Knee joint lateral reconstruction group
|
Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KT2000
Time Frame: 1 year after operation
|
Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg
|
1 year after operation
|
Lysholm
Time Frame: 1 year after operation
|
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.
|
1 year after operation
|
Tegner
Time Frame: 1 year after operation
|
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.
|
1 year after operation
|
IKDC
Time Frame: 1 year after operation
|
International Knee Documentation Committee (IKDC) 2000.
The higher values represent a better outcome.
|
1 year after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI
Time Frame: 1 year after operation
|
Using MRI to exam the healing of the posterolateral ligament reconstructed 1 year after surgery
|
1 year after operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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