Clinical trial NCT05048303: Multicenter Clinical Cohort Study of Modified Flexible Fixation Latarjet Procedure for Recurrent Shoulder Dislocation
Official title: Multicenter Clinical Cohort Study of Modified Flexible Fixation Latarjet Procedure for Recurrent Shoulder Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Dislocation
Keywords: shoulder dislocation
Latarjet procedure
graft remodeling
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A multi-center, prospective, single-arm clinical intervention cohort study.
Primary purpose: TREATMENT

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.


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. )

Primary outcomes:
measure: Change in the Rowe Score
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Secondary outcomes:
measure: Change in the ASES score
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
measure: Change in the Constant-Murley score
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
measure: Change in the Visual Analogue Scale
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
measure: Change in the Range of Motion
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
measure: Change in the bone healing
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
measure: Change in the Samilson-Prieto score
timeFrame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
Other outcomes:
Locations:
Study officials:
References: