Absorption Rate and Bone Ingrowth of Absorbable Anchors Used in Shoulder Dislocation
NCT ID: NCT04977505
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
114 participants
OBSERVATIONAL
2021-04-21
2021-05-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
NCT04460118
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
NCT03023956
Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft
NCT03358173
Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation
NCT02983357
A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations
NCT04056351
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pushlock
Patients with recurrent shoulder dislocation received surgery fixed by pushlock
pushlock
The surgery procedure was performed with pushlock for fixation
Gryphon
Patients with recurrent shoulder dislocation received surgery fixed by Gryphon
gryphon
The surgery procedure was performed with Gryphon for fixation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pushlock
The surgery procedure was performed with pushlock for fixation
gryphon
The surgery procedure was performed with Gryphon for fixation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (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
* (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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guoqing Cui
Role: STUDY_CHAIR
Peking University Third Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PekingUTH
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M2021132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.