Circumferential Lesions of the Glenoid Labrum

This study has been completed.
Sponsor:
Information provided by:
Society of Military Orthopedic Surgeons
ClinicalTrials.gov Identifier:
NCT00849927
First received: February 18, 2009
Last updated: February 21, 2009
Last verified: February 2009
  Purpose

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
Shoulder Instability

Study Type: Observational
Study Design: 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.

Further study details as provided by Society of Military Orthopedic Surgeons:

Primary Outcome Measures:
  • ASES score [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS pain [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • Visual Analog Score Instability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • SANE score [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • SF-12 score [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: January 2003
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Department of Defense active duty members

Criteria

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
  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: NCT00849927

Locations
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
Investigators
Principal Investigator: John M Tokish, MD Society of Military Orthopedic Surgeons
  More Information

Publications:
Responsible Party: John M. Tokish, Chief Sports Medicine, USAF Academy, Society of Military Orthopedic Surgeons
ClinicalTrials.gov Identifier: NCT00849927     History of Changes
Other Study ID Numbers: somos 12-04-01
Study First Received: February 18, 2009
Last Updated: February 21, 2009
Health Authority: United States: Federal Government

Keywords provided by Society of Military Orthopedic Surgeons:
shoulder instability
labral lesions
arthroscopic labral repair
SLAP
triple labrum
circumferential labrum
Pan-labral lesion

ClinicalTrials.gov processed this record on October 21, 2014