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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04459858
Other study ID # 2020-01201; ch20Taha2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 3, 2020
Est. completion date October 31, 2020

Study information

Verified date December 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff tears. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient after an arthroscopic rotator cuff repair - 1 to 4 years postoperative - Presence of pre-operative radiography of the shoulder Exclusion Criteria: - Massive irreparable cuff tear - Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair - Absence of pre-operative radiography in neutral rotation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
data analysis
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.

Locations

Country Name City State
Switzerland Department of Orthopaedics and Traumatology, University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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