An interventional study of Arthroscopic modified individualized flexible Latarjet procedure in Shoulder Dislocation, sponsored by Shenzhen Second People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Shenzhen Second People's Hospital · Not applicable, Interventional, and Treatment
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.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 364 is above the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Shenzhen Second People's Hospital is the lead sponsor of 51 studies on the registry; 8 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24
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Shenzhen Second People's Hospital