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Clinical Trials/NCT04121663
NCT04121663UnknownNot Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country36 target enrollmentStarted: September 22, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
UCLA score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Full seam anchor

Experimental

Intervention: Total arthroscopic rotator cuff repair (Device)

Polyether ether ketone bone anchor

Active Comparator

Intervention: Total arthroscopic rotator cuff repair (Device)

Outcomes

Primary Outcomes

UCLA score

Time Frame: 6 months

Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%

Secondary Outcomes

  • UCLA score(3 months)
  • constant-murley score(3 months)
  • ASES score(3 months)

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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