Shoulder DislocationNCT04977505
Absorption Rate and Bone Ingrowth of Absorbable Anchors Used in Shoulder Dislocation
An observational study of Shoulder Dislocation, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to analyze the absorption rate of Pushlock anchors and Gryphon anchors and the bone ingrowth of the anchor channel by consulting the postoperative CT images of patients with recurrent shoulder dislocation completed by myself. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- pushlock and gryphon
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 28 May 2021
- Phase
- Observational
- 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
Study population: Patients who underwent Cuistow surgery, Bristow surgery, Latarjet surgery or Bankart surgery in Peking University Third Hospital for fixing the dislocated shoulder.
Who may be able to join
- (1) The subject underwent Cuistow surgery, Bristow surgery, Latarjet surgery or Bankart surgery.
- (2) The surgeon was chief physician Cui Guoqing.
- (3) Pushlock anchor (2.9mm) or Gryphon anchor (3.0mm) was used during the operation, and the placement position was the glenoid.
Who cannot join
- (1) Ipsilateral shoulder joint, with a history of surgery.
- (2) Subjects with postoperative infection.
- (3) Subjects with incomplete data (no immediate postoperative CT or no postoperative CT films for more than 2 years).
- (4)Subjects with diabetes.
- (5)Revision surgery for shoulder dislocation.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to analyze the absorption rate of Pushlock anchors and Gryphon anchors and the bone ingrowth of the anchor channel by consulting the postoperative CT images of patients with recurrent shoulder dislocation completed by myself. The investigators will analyze the influence factors of anchor absorption and bone ingrowth, which will provide a reference for improving anchor design and the improvement of surgical techniques.
Read the detailed description
"Recurrent anterior dislocation of the shoulder joint is a common disease of the shoulder joint. The standard treatment methods include soft tissue repair surgery and bone tissue repair surgery. The former refers to arthroscopic labral suture (Bankart repair surgery), and the latter includes Latarjet surgery, Bristow surgery and Cuistow surgery pioneered by our team. Whether it is soft tissue repair surgery or bone tissue repair surgery, anchors are required for suture fixation during the operation.
The anchors currently in use include non-absorbable anchors and absorbable anchors. Non-absorbable anchors include metal anchors and peek material anchors, which remain in the body forever after the operation and cannot be absorbed. The absorbable anchors, in theory, will be absorbed 2 years after surgery.
Non-absorbable anchors have inherent limitations that limit their use. If the non-absorbable anchor loosens and shifts, it can cause severe cartilage damage. If complications such as re-dislocation occurred, revision surgery is required. Revision surgery is complicated because the non-absorbable anchor inserted in the initial surgery occupies the best anchor position. Metal anchors can cause artifacts and affect postoperative MRI imaging.
Therefore, absorbable anchors have gradually become routinely used in shoulder joint dislocation surgery.
The anchors currently used in our hospital for shoulder joint instability include Pushlock anchors from Arthrex and Gryphon anchors from Depuy Mitek. The materials are PLLA/β-TCP and PLGA/β-TCP. The absorption anchor starts to absorb in 1 year and completes absorption in about two years. The anchor tunnel will be filled with bone tissue. However, the investigators have found that the anchor cannot be wholly absorbed as scheduled. During the revision surgery, the original absorbable anchor can still be seen. Clear anchor tunnels can also be seen in CT films after 2 years postoperatively.
Published literature also show that the degradation rate of absorbable anchors is not the same. The literature report that anchors have not completed degradation and bone ingrowth within the time advertised by the manufacturers.
In summary, this study aims to analyze the absorption rate of Pushlock anchors and Gryphon anchors and the bone ingrowth of the anchor tunnel by consulting the postoperative CT films of subjects with recurrent shoulder dislocation completed by myself. The factors that affect anchor absorption and bone ingrowth provide a reference for improving anchor design and the improvement of surgical techniques.
- Conditions
- Shoulder Dislocation
- Being tested
- pushlock, gryphon
- Keywords
- anterior dislocation, anchor
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pushlockDevice
The surgery procedure was performed with pushlock for fixation
gryphonDevice
The surgery procedure was performed with Gryphon for fixation
| Study group | Role | What they receive |
|---|---|---|
| Pushlock | Patients with recurrent shoulder dislocation received surgery fixed by pushlock Receives: Device: pushlock | |
| Gryphon | Patients with recurrent shoulder dislocation received surgery fixed by Gryphon Receives: Device: gryphon |
What is being measured
The primary outcome is the main question the study is designed to answer.
hounsfield unit of anchor tunnel
It is an index used to evaluate the status of bone resorption. It was recorded of last CT films.
Measured: 2 years after surgery
the diameter of anchor tunnel
It is an index used to evaluate the status of bone resorption. It can be measured in the last CT films.
Measured: 2 years after surgery
Hounsfield unit of ossification site
It is an index used to evaluate the status of bone resorption. It was recorded of last CT films.
Measured: 2 years after surgery
Secondary outcomes (2)
unossified area of anchor tunnel
It is an index used to evaluate the status of bone resorption. It can be measured in the last CT films.
Measured: 2 years after surgery
ossification quality score
It is a standard score used to qualify the status of ossification.
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 posted27 Jul 2021
- Study start21 Apr 2021
- Primary completion28 May 2021
- Study completion28 May 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
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
- NCT04977505
- Sponsor's protocol ID
- M2021132
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 27 Jul 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption Rate and Bone Ingrowth of Absorbable Anchors Used in Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT04977505
- Acronym / sponsor ID
- M2021132
- Conditions
- Shoulder Dislocation
- Keywords
- anterior dislocation, anchor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 27 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.
This study aims to analyze the absorption rate of Pushlock anchors and Gryphon anchors and the bone ingrowth of the anchor channel by consulting the postoperative CT images of patients with recurrent shoulder dislocation completed by myself. The investigators will analyze the influence factors of anchor absorption and bone ingrowth, which will provide a reference for improving anchor design and the improvement of surgical techniques.
Detailed description
"Recurrent anterior dislocation of the shoulder joint is a common disease of the shoulder joint. The standard treatment methods include soft tissue repair surgery and bone tissue repair surgery. The former refers to arthroscopic labral suture (Bankart repair surgery), and the latter includes Latarjet surgery, Bristow surgery and Cuistow surgery pioneered by our team. Whether it is soft tissue repair surgery or bone tissue repair surgery, anchors are required for suture fixation during the operation.
The anchors currently in use include non-absorbable anchors and absorbable anchors. Non-absorbable anchors include metal anchors and peek material anchors, which remain in the body forever after the operation and cannot be absorbed. The absorbable anchors, in theory, will be absorbed 2 years after surgery.
Non-absorbable anchors have inherent limitations that limit their use. If the non-absorbable anchor loosens and shifts, it can cause severe cartilage damage. If complications such as re-dislocation occurred, revision surgery is required. Revision surgery is complicated because the non-absorbable anchor inserted in the initial surgery occupies the best anchor position. Metal anchors can cause artifacts and affect postoperative MRI imaging.
Therefore, absorbable anchors have gradually become routinely used in shoulder joint dislocation surgery.
The anchors currently used in our hospital for shoulder joint instability include Pushlock anchors from Arthrex and Gryphon anchors from Depuy Mitek. The materials are PLLA/β-TCP and PLGA/β-TCP. The absorption anchor starts to absorb in 1 year and completes absorption in about two years. The anchor tunnel will be filled with bone tissue. However, the investigators have found that the anchor cannot be wholly absorbed as scheduled. During the revision surgery, the original absorbable anchor can still be seen. Clear anchor tunnels can also be seen in CT films after 2 years postoperatively.
Published literature also show that the degradation rate of absorbable anchors is not the same. The literature report that anchors have not completed degradation and bone ingrowth within the time advertised by the manufacturers.
In summary, this study aims to analyze the absorption rate of Pushlock anchors and Gryphon anchors and the bone ingrowth of the anchor tunnel by consulting the postoperative CT films of subjects with recurrent shoulder dislocation completed by myself. The factors that affect anchor absorption and bone ingrowth provide a reference for improving anchor design and the improvement of surgical techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pushlock | – | Device: pushlockPatients with recurrent shoulder dislocation received surgery fixed by pushlock |
| Gryphon | – | Device: gryphonPatients with recurrent shoulder dislocation received surgery fixed by Gryphon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent Cuistow surgery, Bristow surgery, Latarjet surgery or Bankart surgery in Peking University Third Hospital for fixing the dislocated shoulder.
Key inclusion criteria (3 listed)
- (1) The subject underwent Cuistow surgery, Bristow surgery, Latarjet surgery or Bankart surgery.
- (2) The surgeon was chief physician Cui Guoqing.
- (3) Pushlock anchor (2.9mm) or Gryphon anchor (3.0mm) was used during the operation, and the placement position was the glenoid.
Key exclusion criteria (5 listed)
- (1) Ipsilateral shoulder joint, with a history of surgery.
- (2) Subjects with postoperative infection.
- (3) Subjects with incomplete data (no immediate postoperative CT or no postoperative CT films for more than 2 years).
- (4)Subjects with diabetes.
- (5)Revision surgery for shoulder dislocation.
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 |
|---|---|---|
| pushlockThe surgery procedure was performed with pushlock for fixation | Device | Pushlock |
| gryphonThe surgery procedure was performed with Gryphon for fixation | Device | Gryphon |
Primary outcome
hounsfield unit of anchor tunnel
Time frame: 2 years after surgery
It is an index used to evaluate the status of bone resorption. It was recorded of last CT films.
the diameter of anchor tunnel
Time frame: 2 years after surgery
It is an index used to evaluate the status of bone resorption. It can be measured in the last CT films.
Hounsfield unit of ossification site
Time frame: 2 years after surgery
It is an index used to evaluate the status of bone resorption. It was recorded of last CT films.
2 secondary outcomes
unossified area of anchor tunnel
Time frame: 2 years after surgery
ossification quality score
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 5 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: finished, as of the sponsor's last update on 27 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hounsfield unit of anchor tunnel (time frame: 2 years after surgery). The study lists 3 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 27 Jul 2021.