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

NCT ID: NCT05048303

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-03-31

Brief Summary

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Arthroscopic modified individualized flexible Latarjet procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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. )

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Liu Haifeng, MD

Role: CONTACT

819811255@qq.com

+8613713899307

Other Identifiers

LUWEI

Identifier Type: -

Identifier Source: org_study_id