Non-inferiority Evaluation of Multicenter, Randomized, Si... | NCT04121663

Studies
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

NCT04121663

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Oct 10, 2019Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Shoulder Instability Rotator Cuff Injury

Interventions

Total arthroscopic rotator cuff repair

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2019Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Oct 31, 2020Estimated

First Submitted Date

Sep 25, 2019

First Submission Date that Met QC Criteria

Oct 8, 2019

First Posted Date

Oct 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2019

Last Update Posted Date

Oct 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full seam anchor	Experimental		Device: Total arthroscopic rotator cuff repair
Polyether ether ketone bone anchor	Active Comparator		Device: Total arthroscopic rotator cuff repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total arthroscopic rotator cuff repair	Device	The equivalence of the two devices was compared by using control and experimental instruments during the operation	Full seam anchor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UCLA score	Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%	6 months

Secondary Outcomes

Measure	Description	Time Frame
UCLA score	Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%	3 months
constant-murley score	The higher the score, the better shoulder function.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation
Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor
Subjects were willing and able to sign informed consent

Exclusion Criteria:

Patients with severe osteoporosis；
A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation；
Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)；
Patients with abnormal liver and kidney function [SGPT (ALT) or SGOT (AST) or creatinine (CR)] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened > 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened > 10 s, platelet count (PLT) < 50 *109/L)；
Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study；
Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with；
Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure；
Surgical site peripheral nerve injury；
Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint
High blood pressure control is still not suitable for surgery；
Malignant Tumor Patients；
Researchers believe that there are other circumstances that are not suitable for this clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries