Absorption Rate and Bone Ingrowth of Absorbable Anchors Used in Shoulder Dislocation

NCT04977505 | Completed DMC

• 1 other identifier: M2021132
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shoulder Dislocation

Keywords

anterior dislocation; anchor

Outcome Measures

Primary Outcomes (3)

• hounsfield unit of anchor tunnel

  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

  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

  It is an index used to evaluate the status of bone resorption. It was recorded of last CT films.

  2 years after surgery

Secondary Outcomes (2)

• unossified area of anchor tunnel

  2 years after surgery

• ossification quality score

  2 years after surgery

Study Arms (2)

Pushlock

Patients with recurrent shoulder dislocation received surgery fixed by pushlock

Device: pushlock

Gryphon

Patients with recurrent shoulder dislocation received surgery fixed by Gryphon

Device: gryphon

Interventions

pushlock DEVICE

The surgery procedure was performed with pushlock for fixation

Pushlock

gryphon DEVICE

The surgery procedure was performed with Gryphon for fixation

Gryphon

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent Cuistow surgery, Bristow surgery, Latarjet surgery or Bankart surgery in Peking University Third Hospital for fixing the dislocated shoulder.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

PekingUTH

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Guoqing Cui

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 27, 2021
• Study Start: April 21, 2021
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)