A Prospective Comparative Study of Arthroscopic and Open Surgery in Cuistow Procedure
Primary Purpose
Shoulder Dislocation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
arthroscopic Cuistow
open Cuistow
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Dislocation focused on measuring recurrent anterior shoulder dislocation, Bristow-Latarjet procedure, arthroscopy
Eligibility Criteria
Inclusion Criteria:
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Exclusion Criteria:
- epilepsy
- multidirectional shoulder instability
- concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
Sites / Locations
- PekingUTHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arthroscopic Cuistow
Open Cuistow
Arm Description
Patients who receive arthroscopic Cuistow procedure
Patients who receive open Cuistow procedure
Outcomes
Primary Outcome Measures
ASES score
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
pain VAS score
The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
Secondary Outcome Measures
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction
Bone block position
Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.
Bone union
Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone
Bone union
Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone
Full Information
NCT ID
NCT04952636
First Posted
June 27, 2021
Last Updated
November 28, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04952636
Brief Title
A Prospective Comparative Study of Arthroscopic and Open Surgery in Cuistow Procedure
Official Title
A Prospective Comparative Study of Arthroscopic and Open Surgery in Chinese Unique Inlay Bristow Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the clinical outcomes of arthroscopic and open Chinese Unique Inlay Bristow procedure in treating recurrent anterior shoulder instability.
Detailed Description
Recurrent anterior dislocation of the shoulder joint is a common disorder of the shoulder joint. Patients with recurrent anterior dislocation of the shoulder severely affect movement and quality of life, and severe cases can lead to severe dysfunction of the shoulder joint. Nowadays, arthroscopic Bankart surgery is routinely used to treat such patients. However, the recurrence rate of shoulder dislocation with conventional arthroscopic Bankart repair is high in professional athletes with very high levels of athleticism and in complex patients with large glenoid bone defects. For this population, coracoid transfer surgery (Bristow-Latarjet procedure) is currently considered to have better efficacy.
The Latarjet procedure is now relatively well established internationally; however, this technique has a large osteotomy block and uses two hollow screws to fix the bone block. This is very traumatic and cannot be used in patients with small coracoid, and there is a high incidence of postoperative bone resorption of the bone block, and in the event of severe bone resorption, the screws left behind are more damaging to the subscapularis tendon. In contrast, the Bristow procedure is relatively less invasive, but the early healing rate of the grafted bone block is lower than that of the Latarjet procedure. In response to this problem, the group improved the Bristow procedure in a previous clinical study by using an embedded technique to fix the bone block, which is the first of its kind in the world, and the investigators named it the Chinese Unique Inlay Bristow (Cuistow) procedure. The description and clinical results of this procedure have been accepted by the American Journal of Sports Medicine, and the technique is now a routine procedure in our department.
There is still some debate as to whether the classical coracoid procedure should be performed arthroscopically or open. Open surgery is more traumatic, but relatively easy to perform, with a shorter operative time and a shorter learning curve to master the technique; arthroscopic surgery is less traumatic, with faster recovery, but relatively more expensive and requires higher surgical skills. Some studies have concluded that there is no significant difference between the two in terms of long-term postoperative outcomes and complications. In our previous study, the investigators found that the use of our first " Mortise and Tenon structure " bone displacement fixation resulted in better early postoperative stability and higher postoperative bone healing rates than the traditional coracoid transfer procedure. However, it is unknown whether there is a difference in clinical outcomes and postoperative bone healing rates using open surgery compared to arthroscopic surgery.
In this study, a prospective observational study was conducted in which the advantages and disadvantages of arthroscopic and open surgery for Cuistow procedure were explained to the patient before surgery, and then the patient chose one of the surgical approaches according to his or her own wishes. The functional recovery and bone resorption of the two groups were compared, and the two surgical approaches were evaluated to determine whether there were significant differences in postoperative bone healing rates and clinical outcomes between the two surgical approaches.
In conclusion, the aim of this study was to evaluate the advantages and disadvantages of the two surgical approaches through a comparative study. The investigators wish to provide a complete systematic solution for the treatment of difficult and complex recurrent anterior shoulder dislocations, and to provide an effective remedy for cases of recurrence after Bankart surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
recurrent anterior shoulder dislocation, Bristow-Latarjet procedure, arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Cuistow
Arm Type
Experimental
Arm Description
Patients who receive arthroscopic Cuistow procedure
Arm Title
Open Cuistow
Arm Type
Experimental
Arm Description
Patients who receive open Cuistow procedure
Intervention Type
Procedure
Intervention Name(s)
arthroscopic Cuistow
Intervention Description
peforming the Cuistow Procedure under arthroscopy
Intervention Type
Procedure
Intervention Name(s)
open Cuistow
Intervention Description
peforming the Cuistow Procedure with the traditional open process
Primary Outcome Measure Information:
Title
ASES score
Description
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Time Frame
2 years after surgery
Title
pain VAS score
Description
The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
Active shoulder ranges of motion
Description
internal rotation at the side, and external and internal rotation at 90° of abduction
Time Frame
2 years after surgery
Title
Bone block position
Description
Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.
Time Frame
immediately after surgery
Title
Bone union
Description
Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone
Time Frame
3 months after surgery
Title
Bone union
Description
Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a glenoid defect ≥10%
contact sport athletes with a glenoid defect < 10%
failure after Bankart repair.
Exclusion Criteria:
epilepsy
multidirectional shoulder instability
concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuhan Zhang
Phone
86-15336331337
Email
shuhan.zhang@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoqing Cui
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PekingUTH
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqing Cui, professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Comparative Study of Arthroscopic and Open Surgery in Cuistow Procedure
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