Shoulder DislocationNCT04952636
A Prospective Comparative Study of Arthroscopic and Open Surgery in Cuistow Procedure
A study testing arthroscopic Cuistow and open Cuistow in people with Shoulder Dislocation, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the clinical outcomes of arthroscopic and open Chinese Unique Inlay Bristow procedure in treating recurrent anterior shoulder instability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- arthroscopic Cuistow and open Cuistow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PekingUTH
Beijing, Beijing Municipality
Guoqing Cui, professor
About this study
Official title: A Prospective Comparative Study of Arthroscopic and Open Surgery in Chinese Unique Inlay Bristow Procedure
To evaluate the clinical outcomes of arthroscopic and open Chinese Unique Inlay Bristow procedure in treating recurrent anterior shoulder instability.
Read the 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.
- Conditions
- Shoulder Dislocation
- Being tested
- arthroscopic Cuistow, open Cuistow
- Keywords
- recurrent anterior shoulder dislocation, Bristow-Latarjet procedure, arthroscopy
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic CuistowProcedure or surgery
peforming the Cuistow Procedure under arthroscopy
open CuistowProcedure or surgery
peforming the Cuistow Procedure with the traditional open process
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Cuistow | Experimental | Patients who receive arthroscopic Cuistow procedure Receives: Procedure: arthroscopic Cuistow |
| Open Cuistow | Experimental | Patients who receive open Cuistow procedure Receives: Procedure: open Cuistow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after surgery
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.
Measured: 2 years after surgery
Secondary outcomes (4)
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction
Measured: 2 years after surgery
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.
Measured: immediately after surgery
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
Measured: 3 months after surgery
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
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start6 Nov 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952636
- Sponsor's protocol ID
- M2020294
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Arthroscopic and Open Surgery in Chinese Unique Inlay Bristow Procedure
- ClinicalTrials.gov ID
- NCT04952636
- Acronym / sponsor ID
- M2020294
- Conditions
- Shoulder Dislocation
- Keywords
- recurrent anterior shoulder dislocation, Bristow-Latarjet procedure, arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Cuistow | Experimental | Procedure: arthroscopic CuistowPatients who receive arthroscopic Cuistow procedure |
| Open Cuistow | Experimental | Procedure: open CuistowPatients who receive open Cuistow procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic Cuistowpeforming the Cuistow Procedure under arthroscopy | Procedure or surgery | Arthroscopic Cuistow |
| open Cuistowpeforming the Cuistow Procedure with the traditional open process | Procedure or surgery | Open Cuistow |
Primary outcome
ASES score
Time frame: 2 years after surgery
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
Time frame: 2 years after surgery
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.
4 secondary outcomes
Active shoulder ranges of motion
Time frame: 2 years after surgery
Bone block position
Time frame: immediately after surgery
Bone union
Time frame: 3 months after surgery
Bone union
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Shoulder Dislocation
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anterior Glenohumeral Dislocations
Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoqing Cui study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic Cuistow and open Cuistow in people with Shoulder Dislocation, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuhan Zhang (86-15336331337, shuhan.zhang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES score (time frame: 2 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.