Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04456881

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent Patellar Dislocation	Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anatomical reconstruction group of Patellofemoral ligament	Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament

Arm

Intervention/Treatment

Experimental: anatomical reconstruction group of Patellofemoral ligament

Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction

Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament

Outcome Measures

Primary Outcome Measures

Lysholm score [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.
International Knee Documentation Committee (IKDC) 2000 [1 year after operation]
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Tegner activity level score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China	Beijing	Beijing	China	100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04456881

Other Study ID Numbers:

2014205

First Posted:

Jul 7, 2020

Last Update Posted:

Jul 7, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking University Third Hospital

arthroscopy

medial patellofemoral ligament

Additional relevant MeSH terms:

Patellar Dislocation

Study Results

No Results Posted as of Jul 7, 2020