Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01039571
First received: December 23, 2009
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair.

Our null hypothesis is there are no differences in clinical and structural results


Condition Intervention
Rotator Cuff Tear
Procedure: double row repair

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Randomized Case-controlled Blinded Study of Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Retear rate in each group(single row repair group and double row repair group) [ Time Frame: MRI after 6 months from surgery ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: January 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: double row repair
    double row repair for torn rotator cuff were performed to compare with the conventional single row repair
    Other Name: dual row repair
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Rotator cuff tear patients

Criteria

Inclusion Criteria:

  • Rotator cuff tears
  • tear size between 2cm~4cm

Exclusion Criteria:

  • Subscapularis tear requiring repair
  • open repair
  • any prior history of surgery on the affected shoulder
  • any fracture history around shoulder girdle(clavicle, humerus, acromion)
  • glenohumeral joint arthritis
  • inflammatory arthropathy
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039571

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Publications:

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01039571     History of Changes
Other Study ID Numbers: 2005-12-005
Study First Received: December 23, 2009
Last Updated: April 21, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Samsung Medical Center:
rotator cuff tear
arthroscopic repair
single row repair
double row repair
retear rate

ClinicalTrials.gov processed this record on October 22, 2014