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Circumferential Lesions of the Glenoid Labrum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849927
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
Information provided by:
Society of Military Orthopedic Surgeons

Brief Summary:

Objective: Symptomatic pan-labral or circumferential (360 degree) tears of the glenohumeral labrum are an uncommon injury. The purpose of this study is to report the prospective surgical results of circumferential lesions of the glenoid labrum using validated outcome instruments.

Methods: From July 2003 to May 2006, 41 shoulders in 39 patients with mean age of 25.1 years (range, 17 to 38) were prospectively enrolled in a multi-center study (3 surgeons) and treated for a circumferential (360-degree) lesion of the glenoid labrum. There were 34 men and 5 women, all with a primary diagnosis of pain and recurrent shoulder instability. All patients underwent arthroscopic repair of the circumferential labral tear with a mean of 7.1 suture anchors (range, 6 to 9). The outcomes in 39 of 41 shoulders (92.7% follow-up) were assessed at a mean final follow-up of 31.8 months (range, 24 to 53 months) with VAS pain and instability scales (0 to 10), a physical examination, the Single Assessment Numeric Evaluation Score (SANE), the American Shoulder and Elbow Surgeons Score (ASES), and the SF-12 score.

Condition or disease
Shoulder Instability

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circumferential Lesions of the Glenoid Labrum: A Prospective Cohort Study of Arthroscopic Repair With Minimum 2-Year Follow-up: A Multi-Center Study.
Study Start Date : January 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Primary Outcome Measures :
  1. ASES score [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. VAS pain [ Time Frame: 5 yrs ]
  2. Visual Analog Score Instability [ Time Frame: 5 years ]
  3. SANE score [ Time Frame: 5 yrs ]
  4. SF-12 score [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Department of Defense active duty members

Inclusion Criteria:

  • Surgical documentation of Pan Labral Lesion of shoulder
  • Pre-operative documentation of outcomes scores

Exclusion Criteria:

  • lacking a Pan labral lesion
  • other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear

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 identifier (NCT number): NCT00849927

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United States, California
Navy Medical Center San Diego
San Diego, California, United States, 92134
United States, Colorado
US Air Force Academy
Colorado Springs, Colorado, United States, 80840
Sponsors and Collaborators
Society of Military Orthopedic Surgeons
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Principal Investigator: John M Tokish, MD Society of Military Orthopedic Surgeons
Publications of Results:
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Responsible Party: John M. Tokish, Chief Sports Medicine, USAF Academy, Society of Military Orthopedic Surgeons Identifier: NCT00849927    
Other Study ID Numbers: somos 12-04-01
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Keywords provided by Society of Military Orthopedic Surgeons:
shoulder instability
labral lesions
arthroscopic labral repair
triple labrum
circumferential labrum
Pan-labral lesion