CClinicalTrials.gg
Status unknownNCT04121663MST-002Updated Oct 10, 2019

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

An interventional study of Total arthroscopic rotator cuff repair in Shoulder Instability Rotator Cuff Injury, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Shoulder Instability Rotator Cuff Injury

Keywords

  • Shoulder instability
  • Rotator cuff injury
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 36 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe osteoporosis;
  2. A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation;
  3. Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.);
  4. 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);
  5. Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study;
  6. Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with;
  7. Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure;
  8. Surgical site peripheral nerve injury;
  9. Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint
  10. High blood pressure control is still not suitable for surgery;
  11. Malignant Tumor Patients;
  12. Researchers believe that there are other circumstances that are not suitable for this clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Full seam anchor

    Device: Total arthroscopic rotator cuff repair

  • Active comparator
    Polyether ether ketone bone anchor

    Device: Total arthroscopic rotator cuff repair

Interventions

  • DeviceTotal arthroscopic rotator cuff repair

    The equivalence of the two devices was compared by using control and experimental instruments during the operation

06

What researchers measure

Primary outcomes

  1. UCLA score

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

    Time frame: 6 months

Secondary outcomes

  1. UCLA score

    Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%

    Time frame: 3 months

  2. constant-murley score

    The higher the score, the better shoulder function.

    Time frame: 3 months

  3. ASES score

    The higher the score, the better shoulder function.

    Time frame: 3 months

07

Study locations

1 site
  • Full seam anchor
    Hangzhou, Zhejiang 310000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04121663
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Oct 10, 2019
Start date
Sep 22, 2019
Primary completion
Apr 30, 2020 (estimated)
Completion
Oct 31, 2020 (estimated)
Last update
Oct 10, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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