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Clinical Trials/NCT05048303
NCT05048303
Not yet recruiting
Not Applicable

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

Shenzhen Second People's Hospital0 sites364 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Dislocation
Sponsor
Shenzhen Second People's Hospital
Enrollment
364
Primary Endpoint
Change in the Rowe Score
Status
Not yet recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
March 31, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shenzhen Second People's Hospital
Responsible Party
Sponsor

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 (
  • Glenoid bone defect\>20%
  • Glenoid defect\>15% and ISIS\>6
  • 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. )

Outcomes

Primary Outcomes

Change in the Rowe Score

Time Frame: Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24

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.

Secondary Outcomes

  • Change in the Range of Motion(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)
  • Change in the Constant-Murley score(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)
  • Change in the Samilson-Prieto score(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)
  • Change in the ASES score(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)
  • Change in the Visual Analogue Scale(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)
  • Change in the bone healing(Preoperative, Day 1, Month 6, Month 12, Month 18, Month 24)

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