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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00828256
First received: January 22, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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

Condition Intervention
Rotator Cuff Tear
Procedure: arthroscopy of shoulder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Outcome Study of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008, at the Soroka University Medical Center, Beer Sheva, Israel

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • evidence of an anatomic repair of the rotator cuff proved by ultrasound [ Time Frame: immidiate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • high constant score [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: arthroscopy of shoulder
    arthroscopic repair of chronic rotator cuff tears
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

80 patients, above 18 years of age, who had had an arthroscopic repair of chronic rotator cuff tear between the years 2005-2008.

Criteria

Inclusion Criteria:

  • Age over 18 years
  • Arthroscopic repair of chronic rotator cuff tear
  • Operation done after January 2005
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Asaf Acker, Soroka University Medical Center, Beer Sheva, Israel
ClinicalTrials.gov Identifier: NCT00828256     History of Changes
Other Study ID Numbers: sor477308ctil, isrctn9930305
Study First Received: January 22, 2009
Last Updated: January 22, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
arthroscopic repair
rotator cuff
tears
shoulder
chronic tear of rotator cuff

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014