NCT03358316

Brief Summary

To evaluate the association between rotator cuff tear and the proximal migration of humeral head

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 26, 2017

Last Update Submit

November 29, 2017

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff TearMagnetic Resonance Imaginghumeral migration

Outcome Measures

Primary Outcomes (1)

  • Correlation between rotator cuff tear size and the superior migration of humeral head

    Correlation between rotator cuff tear size and the superior migration of humeral head

    1 year

Secondary Outcomes (1)

  • Correlation between rotator cuff fatty degeneration and the superior migration

    1 year

Study Arms (1)

cuff tear patients

Patients with cuff tear

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

60 patients with cuff tear

You may qualify if:

  • Patient receive Magnetic Resonance Imaging half year before enrollment, showing supraspinatus tear
  • Patient receive X-ray half year before enrollment
  • the duration between the two examinations was no longer than 1 week
  • no past history of surgery in the selected shoulders

You may not qualify if:

  • patients who cannot receive MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Yichong Zhang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichong Zhang, MD

CONTACT

15210802766875274428@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of orthopaedics and trauma

Study Record Dates

First Submitted

November 26, 2017

First Posted

November 30, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share