Multicenter Clinical Cohort Study of Modified Flexible Fixation Latarjet Procedure for Recurrent Shoulder Dislocation

The shoulder joint is the most flexible joint of human body and shoulder joint dislocation is the most common joint dislocation of human body. Currently, there are different treatments for anterior shoulder dislocation, but for young patients with high sports requirements and apparent glenoid defect, soft tissue repair is not enough otherwise patients will suffer a high recurrent rate.

In 1954, M. Latarjet invented the coracoid process osteotomy and transposition technique, called the Latarjet procedure, which was a bony repair technique and was later promoted by G. Walch. This technique not only reconstructs the defect glenoid, the sling effect attached to the conjoint tendon also strengthens the anterior and inferior structure. Due to the advantages of low recurrence rate after Latarjet procedure, high rate of patients returning to sports and high satisfaction, it has become the only surgery that has been widely used in more than ten similar surgeries in history. In 2007, French physician Lafosse successfully completed the technique under arthroscopy. However, this surgery traditionally uses screws to fix the bone block, but screw fixation has difficulties like exposed nail head, uncertain bone block positioning, and high absorption rate of the bone block. In 2012, P.Boileau further improved this technique, innovating to avoid the above-mentioned complications through suture button fixation. However, since the Latarjet procedure was invented for decades, scholars have been worried about the unavoidable defects of this technique including the destruction of the coracoacomial arch, pectoralis minor injury and a series of complications caused by non-anatomical reconstruction of the glenoid.

In order to further develop this technology, make it more simple, easy to promote, and safer, based on our clinical and basic research on flexible fixation Latarjet technique for more than 8 years, we have innovatively developed an individualized and improved flexible fixation Latarjet technique that preserves the coracoacomial arch. We assumed that our modified technique, which retains the coracoacomial arch, 1) has the same satisfactory clinical effect. 2) The individualized reconstruction of glenoid defect is more identical with the biomechanics of the shoulder joint. The bone block will finally be remodeled according to the best fit circle. 3) The tiny subscapular tendon split is less damaged and safer.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Arthroscopic modified individualized flexible Latarjet procedure

• Study Type: Interventional
• Enrollment (Anticipated): 364
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Haifeng, MD; Phone Number: +8613713899307; Email: 819811255@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-59 years, gender unlimited.
• Patients with recurrent shoulder dislocation who were judged by clinicians to be suitable for modified flexible fixation Latarjet procedure according to surgical indications (1. Glenoid bone defect>20% 2. Glenoid defect>15% and ISIS>6 3. Glenoid defect>10% and competitive athletes)
• Volunteers to join the study and sign informed consent

Exclusion Criteria:

• Clinical and imaging diagnosis combined with other shoulder diseases, such as frozen shoulder, rotator cuff injury, shoulder joint degeneration.
• Basic diseases of important organs ( including severe osteoporosis, dysfunction of important organs, connective tissue diseases, neuropsychiatric disorders, epilepsy, etc. )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individualized Lutajet operative group; Arthroscopic modified individualized flexible Latarjet procedure with preservation of the coracoacromial arch. During the procedure, we perform coracoid osteotomy with preservation of coracoacromial arch, then split subscapular tendon, transfer the bone graft and fix it with double button under arthroscopy.

Procedure: Arthroscopic modified individualized flexible Latarjet procedure; The modifications were as follows: (1)the coracoid graft and conjoint tendon were prepared using a mini-open technique with an incision of 2.5 cm and coracoacromial ligament were preserved. A total of 2 bone tunnels were drilled. (2)The anterior (including part of the incision used for obtaining the graft), standard antelateral, and posterior portals were set. (3) The glenoid was marked at the 4-o'clock position, and then the subscapularis muscle was split. (4)The glenoid tunnel was drilled where the suture linked to the graft was passed, and the graft was pulled to the glenohumeral joint via the sutures. A knotless suture anchor for antirotation (PushLock; Arthrex) was fixed to the glenoid to prevent rotation of the graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Rowe Score	Dr. Carter R. Rowe, an orthopedic shoulder specialist at the Massachusetts General Hospital in Boston, USA, proposed in the JBJS magazine in the United States in 1978 that the Rowe score scale for the evaluation of the clinical effects of repair surgery for shoulder joint instability. Including stability, mobility and functional evaluation, the higher the score, the higher the stability and the better the shoulder function.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ASES score	The ASES (American Association of Shoulder and Elbow Surgery scores) are the shoulder joint function evaluation standards adopted by the American Association of Shoulder and Elbow Surgeons in 1993. The system is a percentile system that needs to be converted. The pain in the assessment part of the patient and the cumulative daily activities each account for 50%. The full score is 100 points. The higher the score, the better the shoulder joint function.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Change in the Constant-Murley score	The Constant-Murley Shoulder Scoring Scale was designed by Christopher Constant and Alan Murley in 1986. It is mainly used to assess the severity of shoulder-related diseases. The scale has good reliability and validity, including pain and function. , Mobility and muscle strength, the total score is 100, the higher the score, the better the function.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Change in the Visual Analogue Scale	The visual analogue scale (VAS) is used for pain assessment. It is widely used in clinical practice in China. The basic method is to use a moving ruler about 10cm long, with 10 scales on one side, and the two ends are respectively "0" and "10" points. A point of 0 means no pain. A score of 10 represents the most severe pain that is unbearable.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Change in the Range of Motion	The degree of movement of the shoulder joint can reflect the recovery of shoulder joint function, including flexion, extension, abduction, adduction, external rotation and internal rotation.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Change in the bone healing	Through CT scan and 3D reconstruction, we detect the change of bone healing and reshaping during different time period.	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Change in the Samilson-Prieto score	Through X ray of true AP view to evaluate the degeneration of the shoulder joint	Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: shoulder dislocation; Latarjet procedure; graft remodeling
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: LUWEI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No