NCT04461431

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

June 26, 2020

Last Update Submit

July 1, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • IKDC

    International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.

    1 year after operation

Secondary Outcomes (1)

  • MRI

    1 year after operation

Study Arms (1)

Knee joint lateral reconstruction group

EXPERIMENTAL
Procedure: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee

Interventions

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

Knee joint lateral reconstruction group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 8, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

January 1, 2022

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations