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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01805050
Other study ID # HAGL
Secondary ID
Status Completed
Phase N/A
First received March 4, 2013
Last updated March 20, 2017
Start date November 2013
Est. completion date March 2014

Study information

Verified date March 2017
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion.


Description:

The aim of the study is to describe and document the results of a case serie after an arthroscopically intervention to correct the anterior instability in the shoulder joint with one primary parameter (WOSI-Score) and several secondary parameters, which are used in the daily clinical routine (e.g.clinical examination, several questionnaires). The results of these parameters will be used to document the mid-term results (> 1 year after surgery).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- arthroscopically repair of the anterior instability of the shoulder due an HAGL lesion (performed by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey at the Schulthess Klinik)

- patients =18 years

- written informed consent

Exclusion Criteria:

- additional surgeries at the affected side after the index surgery (arthroscopically repair of the anterior instability due an HAGL lesion)

- non-compliance

- disorders which handicap or inhibit the patient to follow the orders of the clinical testers

- request of the patient

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Arthroscopically repair of the anterior shoulder instability
Arthroscopically repair of the anterior shoulder instability

Locations

Country Name City State
Switzerland Schulthess Klinik Zürich Canton of Zürich

Sponsors (1)

Lead Sponsor Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary WOSI-Score expected average of 2 years
Secondary Sociodemographic Dates expected average of 2 years
Secondary x-ray images expected average of 2 years
Secondary Constant-Murley Score expected average of 2 years
Secondary Rowe - Score expected average of 2 years
Secondary SSV (Simple Shoulder Value) expected average of 2 years
Secondary SST (Simple Shoulder Test) expected average of 2 years
Secondary Measurement of the abduction strength expected average of 2 years
Secondary Measurement of the external rotation strength expected average of 2 years
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