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

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05048303
• Other study ID #: LUWEI
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2021
• Source: Shenzhen Second People's Hospital
• Contact: Liu Haifeng, MD
• Phone: +8613713899307
• Email: 819811255[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 364
• Est. completion date: March 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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. )

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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