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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04461431
Other study ID # 2014185
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2022

Study information

Verified date July 2020
Source Peking University Third Hospital
Contact Ping Liu
Phone 13683670396
Email bjusm@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 1, 2022
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Arthroscopic anatomical reconstruction of the posterolateral structure of the knee
Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee

Locations

Country Name City State
China Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary KT2000 Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg 1 year after operation
Primary Lysholm 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
Primary Tegner 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
Primary IKDC International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome. 1 year after operation
Secondary MRI Using MRI to exam the healing of the posterolateral ligament reconstructed 1 year after surgery 1 year after operation
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