NCT04459858

Brief Summary

This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 3, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

July 1, 2020

Last Update Submit

December 14, 2020

Conditions

Keywords

Critical Shoulder Angle (CSA)Greater Tuberosity Angle (GTA)

Outcome Measures

Primary Outcomes (1)

  • Change in Constant Score

    This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and activity of daily life (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 Points (the higher the score the better the shoulder function).

    1 year (before surgery and 1 year after surgery)

Study Arms (1)

rotator cuff lesion

patients treated for traumatic or degenerative rotator cuff lesion

Other: data analysis

Interventions

Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR\_USB). The GTA (determined as the angle between a "line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity") is determined.

rotator cuff lesion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients treated for traumatic or degenerative rotator cuff lesion at the University Hospital Basel between January 2015 and January 2019.

You may qualify if:

  • Patient after an arthroscopic rotator cuff repair
  • to 4 years postoperative
  • Presence of pre-operative radiography of the shoulder

You may not qualify if:

  • Massive irreparable cuff tear
  • Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair
  • Absence of pre-operative radiography in neutral rotation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Mohy Taha, Dr. med.

    Department of Orthopaedics and Traumatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

June 3, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations