NCT04960137

Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor

Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.

Detailed description

The product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. The clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. This trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.

Conditions

• Shoulder Dislocation

Interventions

Type	Name	Description
DEVICE	button plates fixation system	The button plates fixation system consists of fixing plate, prefabricated mix, button and fuse. In the process of use, the fuse plays the role of guiding the fixed plate through, pulling the button and shortening the distance between the button and the fixed plate. The prefabricated mix is pre-worn between the button and the fixed plate, and the lead pulls the distance between the fixed plate and the button after tightening and fixing. Prefabricated mix, make mix tight and knot. Finish the preliminary work of fixing.
DEVICE	Non-absorbable Suture Anchor	A conventional device used in surgery for shoulder dislocation.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-09-30
• Completion: 2019-02-28
• First posted: 2021-07-13
• Last updated: 2021-07-21

Locations

1 site across 1 country: China