Circumferential Lesions of the Glenoid Labrum

NCT00849927 | Completed

• 1 other identifier: somos 12-04-01
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Instability

Keywords

shoulder instability; labral lesions; arthroscopic labral repair; SLAP; triple labrum; circumferential labrum; Pan-labral lesion

Outcome Measures

Primary Outcomes (1)

• ASES score

  5 years

Secondary Outcomes (4)

• VAS pain

  5 yrs

• Visual Analog Score Instability

  5 years

• SANE score

  5 yrs

• SF-12 score

  5 years

Eligibility Criteria

• Age: 17 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Department of Defense active duty members

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Society of Military Orthopedic Surgeons: lead

Study Sites (2)

Navy Medical Center San Diego

San Diego, California, 92134, United States

Location

US Air Force Academy

Colorado Springs, Colorado, 80840, United States

Location

Related Publications (1)

• Lo IK, Burkhart SS. Triple labral lesions: pathology and surgical repair technique-report of seven cases. Arthroscopy. 2005 Feb;21(2):186-93. doi: 10.1016/j.arthro.2004.09.022.

  PMID: 15689868 RESULT

Study Officials

• John M Tokish, MD

  Society of Military Orthopedic Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 24, 2009
• Study Start: January 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

US (2)