NCT05484271

Brief Summary

The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.

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
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

15 days

First QC Date

August 1, 2022

Last Update Submit

August 1, 2022

Conditions

Keywords

Rotator Cuff TearsMiddle Glenohumeral LigamentArthroscopic Anatomy

Outcome Measures

Primary Outcomes (1)

  • The arthroscopic tear position (Anetrior/Middle/Posterior)

    The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor.

    During the surgery

Study Arms (3)

Leaf-like and Cord-like type

Under arthroscopy, the anatomy of middle glenohumeral ligament was leaf-like or cord-like.

Procedure: Rotator cuff repair

Absent type

Under arthroscopy, the anatomy of middle glenohumeral ligament was absent.

Procedure: Rotator cuff repair

Burford complex type

Under arthroscopy, the anatomy of middle glenohumeral ligament manifested the burford complex.

Procedure: Rotator cuff repair

Interventions

The patients received the arthroscopic rotator cuff repair.

Absent typeBurford complex typeLeaf-like and Cord-like type

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rotator cuff tears received the arthroscopic rotator cuff repair.

You may qualify if:

  • partial or full-thickness but reparable rotator cuff tear;
  • small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
  • no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.

You may not qualify if:

  • massive rotator cuff tears being defined by DeOrio and Cofied;
  • patients with osteoarthritis of the glenohumeral joint;
  • trauma or a history of surgery at the shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 2, 2022

Study Start

August 5, 2022

Primary Completion

August 20, 2022

Study Completion

August 28, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07