- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977505
Absorption Rate and Bone Ingrowth of Absorbable Anchors Used in Shoulder Dislocation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China
- PekingUTH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pushlock
Patients with recurrent shoulder dislocation received surgery fixed by pushlock
|
The surgery procedure was performed with pushlock for fixation
|
Gryphon
Patients with recurrent shoulder dislocation received surgery fixed by Gryphon
|
The surgery procedure was performed with Gryphon for fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years after surgery
|
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.
|
2 years after surgery
|
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 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
unossified area 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.
|
2 years after surgery
|
ossification quality score
Time Frame: 2 years after surgery
|
It is a standard score used to qualify the status of ossification.
|
2 years after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Guoqing Cui, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2021132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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