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NCT00828256 Clinical Trial

Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008

Rotator Cuff Tear Clinical Trial

Official title:
Outcome Study of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008, at the Soroka University Medical Center, Beer Sheva, Israel

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00828256
Other study ID # sor477308ctil
Secondary ID isrctn9930305
Status Enrolling by invitation
Phase N/A
First received January 22, 2009
Last updated January 22, 2009
Start date February 2009
Est. completion date June 2009

Study information
Verified date January 2009
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results.

The aim of this study is to estimate the anatomic and functional results of the arthroscopic repair among the patients of the orthopedic department at the Soroka University Medical Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair of the rotator cuff is the better surgical technique.

Methods: study population - 80 patients who had had an arthroscopic repair of the rotator cuff between the years 2005-2008 at the SUMC.

Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation not before 2005.

Study design:

1. Data base Collection.

2. Inviting the patients for physical examination + ultrasound examination of the operated shoulder + filling out questionnaires (SF36, CONSTANT SCORE)

3. Statistical analysis

4. Publication

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date June 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age over 18 years

- Arthroscopic repair of chronic rotator cuff tear

- Operation done after January 2005

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• arthroscopy of shoulder
arthroscopic repair of chronic rotator cuff tears

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary evidence of an anatomic repair of the rotator cuff proved by ultrasound immidiate No
Secondary high constant score 6 months after surgery No
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