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Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery

2019-10-16 10:39:39 | BioPortfolio

Summary

Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery

Description

This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application

Study Design

Conditions

Shoulder Instability Rotator Cuff Injury

Intervention

Total arthroscopic rotator cuff repair

Location

Full seam anchor
Hangzhou
Zhejiang
China
310000

Status

Active, not recruiting

Source

Second Affiliated Hospital, School of Medicine, Zhejiang University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:39-0400

Clinical Trials [1830 Associated Clinical Trials listed on BioPortfolio]

Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008

Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgi...

Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of...

Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair

During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of th...

Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem...

Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair...

PubMed Articles [8730 Associated PubMed Articles listed on BioPortfolio]

Does arthroscopic preemptive extensive rotator interval release reduce postoperative stiffness after arthroscopic rotator cuff repair?: a prospective randomized clinical trial.

To investigate whether preemptive extensive rotator interval (RI) release during arthroscopic rotator cuff repair (ARCR) would reduce postoperative stiffness.

Single Assessment Numeric Evaluation (SANE) correlates with American Shoulder and Elbow Surgeons score and Western Ontario Rotator Cuff index in patients undergoing arthroscopic rotator cuff repair.

Patient-reported outcomes continue to grow in importance. This study compared the Single Assessment Numeric Evaluation (SANE) score with the American Shoulder and Elbow Surgeons (ASES) score and West...

Arthroscopic rotator cuff repair using a transosseous knotless anchor (ATOK).

This article reviews the clinical and radiographic outcomes in a noninferiority trial use of a transosseous knotless anchor to perform arthroscopic rotator cuff repairs in a patient cohort that have a...

Arthroscopic Rotator Cuff Repair: A Systematic Review of Overlapping Meta-Analyses.

Rotator cuff tears are a common pathology, with an increasing number of repairs being performed arthroscopically. The purpose of this study was to systematically review the results in the current meta...

Non-anatomic arthroscopic repair of massive rotator cuff tears versus anatomic complete arthroscopic repair: a case-control study.

To investigate whether a non-anatomic arthroscopic repair of massive rotator cuff tear (RCT) produces satisfactory clinical outcomes comparable to those of an anatomic complete arthroscopic repair.

Medical and Biotech [MESH] Definitions

Rapidly destructive shoulder joint and bone disease found mainly in elderly, and predominantly in women. It is characterized by SHOULDER PAIN; JOINT INSTABILITY; and the presence of crystalline CALCIUM PHOSPHATES in the SYNOVIAL FLUID. It is associated with ROTATOR CUFF INJURIES.

Compression of the rotator cuff tendons and subacromial bursa between the humeral head and structures that make up the coracoacromial arch and the humeral tuberosities. This condition is associated with subacromial bursitis and rotator cuff (largely supraspinatus) and bicipital tendon inflammation, with or without degenerative changes in the tendon. Pain that is most severe when the arm is abducted in an arc between 40 and 120 degrees, sometimes associated with tears in the rotator cuff, is the chief symptom. (From Jablonski's Dictionary of Syndromes and Eponymic Diseases, 2d ed)

Injuries to the ROTATOR CUFF of the shoulder joint.

The musculotendinous sheath formed by the supraspinatus, infraspinatus, subscapularis, and teres minor muscles. These help stabilize the head of the HUMERUS in the glenoid fossa and allow for rotation of the SHOULDER JOINT about its longitudinal axis.

The occurrence of highly polymorphic mono- and dinucleotide MICROSATELLITE REPEATS in somatic cells. It is a form of genome instability associated with defects in DNA MISMATCH REPAIR.

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