Viewing Study NCT04460118


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Study NCT ID: NCT04460118
Status: COMPLETED
Last Update Posted: 2020-07-07
First Post: 2020-06-30
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Sponsor: Peking University Third Hospital
Organization:

Study Overview

Official Title: Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Status: COMPLETED
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.
Detailed Description: Background:Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: