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

Primary Purpose

Shoulder Dislocation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arthroscopic modified individualized flexible Latarjet procedure
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring shoulder dislocation, Latarjet procedure, graft remodeling

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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. )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Individualized Lutajet operative group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Change in the bone healing
    Through CT scan and 3D reconstruction, we detect the change of bone healing and reshaping during different time period.
    Change in the Samilson-Prieto score
    Through X ray of true AP view to evaluate the degeneration of the shoulder joint

    Full Information

    First Posted
    July 27, 2021
    Last Updated
    September 8, 2021
    Sponsor
    Shenzhen Second People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05048303
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shenzhen Second People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Dislocation
    Keywords
    shoulder dislocation, Latarjet procedure, graft remodeling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A multi-center, prospective, single-arm clinical intervention cohort study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    364 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individualized Lutajet operative group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Arthroscopic modified individualized flexible Latarjet procedure
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in the Rowe Score
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Change in the ASES score
    Description
    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
    Title
    Change in the Constant-Murley score
    Description
    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
    Title
    Change in the Visual Analogue Scale
    Description
    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
    Title
    Change in the Range of Motion
    Description
    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
    Title
    Change in the bone healing
    Description
    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
    Title
    Change in the Samilson-Prieto score
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    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. )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liu Haifeng, MD
    Phone
    +8613713899307
    Email
    819811255@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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