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

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ClinicalTrials.gov Identifier: NCT01039571
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:

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 or disease Intervention/treatment
Rotator Cuff Tear Procedure: double row repair

Study Type : Observational
Actual Enrollment : 71 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Retear rate in each group(single row repair group and double row repair group) [ Time Frame: MRI after 6 months from surgery ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039571


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

Publications:

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01039571     History of Changes
Other Study ID Numbers: 2005-12-005
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries