Shoulder InstabilityNCT00849927
Circumferential Lesions of the Glenoid Labrum
An observational study of Shoulder Instability, run by Society of Military Orthopedic Surgeons at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Instability
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 38 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Department of Defense active duty members
Who may be able to join
- Surgical documentation of Pan Labral Lesion of shoulder
- Pre-operative documentation of outcomes scores
Who cannot join
- lacking a Pan labral lesion
- other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear
Trial locations and contacts
2 sites in 1 country.
United States2 sites
US Air Force Academy
Colorado Springs, Colorado, 80840
Navy Medical Center San Diego
San Diego, California, 92134
About this study
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.
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.
Read the detailed description
Patient Demographics A total of 41 shoulders (34 men, 5 women) with mean age of 25.1 years (range, 17 to 38 years) were prospectively enrolled. 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). Thirty-seven of 39 patients were right handed. The dominant shoulder was affected in 30 shoulders, non-dominant in 11. Every patient had a primary chief complaint of shoulder pain with a history of anterior and/or posterior shoulder instability. All had a traumatic onset of their symptoms, twelve as a result of contact sports and had failed initial non-operative management. Two patients had had a previous operation, including one patient with a previous open Bankart, 4 years prior to index operation, and another that had a previous posterior arthroscopic "labral repair" which subsequently sustained an anterior dislocation. This was revised with open inferior capsular shift, 2 years prior to index operation. Twenty-six shoulders presented with clear evidence of primary anterior instability. These patients clearly remembered the initial dislocation event and demonstrating an abducted-externally rotated arm at the time of dislocation. Twenty-four of these patients also had pre-reduction radiographs showing anterior dislocation. An additional five patients in the group had variable levels of glenoid bone loss (5-10%), with small Hill-Sachs injuries. Nine shoulders had clear evidence of posterior instability as evidenced by these patients clearly remembering their initial dislocation event, and demonstrating a forward flexed, adducted, and internally rotated position of the arm at the time of dislocation. The remaining six shoulders could not discern between anterior or posterior instability as a primary direction.
All physical examinations were performed by the treating orthopedic surgeon. All shoulders were compared to the contralateral side for range of motion, strength, tenderness, and provocative maneuvers. Range of motion was examined in forward flexion, abduction, and external and internal rotation at 00 and 90 0 of abduction. As part of our normal protocol, values not significantly different from the contralateral side were recorded as "normal". Any value noted to be abnormal was to be recorded in degrees, or in the case of internal rotation at 00, the spinal level. On physical examination no patient was noted to have a significant loss of active or passive motion in flexion, abduction, internal rotation, or external rotation at 00. Thirty-nine of the 41 shoulders demonstrated a positive apprehension sign20, and thus arms were not taken to maximum external rotation in the abducted position in these patients. Strength testing was accomplished with manual muscle testing compared to the opposite arm in all 39 patients. Specific testing included shoulder abduction, internal and external rotation at 00, resisted scaption, lift-off and belly press testing20, as well as elbow flexion and extension, wrist flexion and extension, and interosseous muscle testing. No significant deficit was noted in any of these positions. All patients had pain induced limitation of strength testing during an active compression test20. Provocative maneuvers included anterior and posterior load and shift testing, an anterior apprehension test, a push-pull test for posterior instability, and an active compression test20 . Thirty-nine of 41 shoulders had a positive apprehension test20. Care was taken to place the patient with their arm in 90 degrees of abduction and increasing external rotation. Patients were asked to discern when they became symptomatic, and then asked whether the shoulder felt like it was "coming out" or if their symptoms were just pain. A positive apprehension test was defined as a sensation of the former. All 39 patients had a positive push-pull test for posterior laxity 20and pain. This test is performed by placing the patient supine on the examining table with the arm placed in 90 degrees of abduction and neutral rotation. The wrist is grasped and "pulled" by the examiner with one hand, while the other hand is used to "push" the shoulder backward. A positive test is signified by subluxation of the joint with a reproduction of the patient's symptoms. Impingement signs including Neer's sign, Hawkin's sign, and painful arc were performed on all 39 patients 20. At least one of the signs was positive in all patients. An active compression test was performed on all 39 patients, and noted to be positive with pain and weakness in all patients. No patient demonstrated an increased sulcus sign, or any sign of hyperlaxity.
MRIs were obtained in all 41 shoulders and all radiologic reports were reviewed. Thirty of 41 of these MRI's were done in conjunction with a gadolinium contrast arthrogram. Intraoperatively, all patients underwent an examination under anesthesia with particular attention directed toward anterior and posterior laxity examinations compared to the opposite side according to the grading system for instability established by the American Shoulder and Elbow Surgeons 21,22. Inferior laxity was measured by a sulcus sign measured in centimeters from the edge of the acromion to the top of the humeral head. At arthroscopy, all patients demonstrated complete circumferential tear of the glenoid labrum. One patient had an additional complete radial split of the labrum at the 1 o'clock position (anteriorly), which was repaired. The average patient had 7.1 anchors placed (range, 6-9). Post-operative examination while still under anesthesia showed restoration of normal anterior and posterior glenohumeral translation "to the rim".
Post-operatively, patients were seen at 2 weeks, 6 weeks, and 3 months, 6 months, one year, and yearly after that. History was taken with particular attention to recurrence of dislocation or feelings of apprehension or pain. Physical examination beginning at 3 months assessed range of motion, anterior apprehension, and posterior reproduction of symptoms using a push-pull test20. In addition, strength testing was accomplished, as was an active compression test. Patient outcomes were re-accomplished for the SANE, modified ASES and SF-12 visits at each follow-up visit beginning at 6 weeks. In addition, each patient was asked if he or she would undergo the surgery again. All surveys were administered using a standard form, and entered into the SOMOS database. Data was combined among surgeons using de-identified patient data.
- Conditions
- Shoulder Instability
- Keywords
- shoulder instability, labral lesions, arthroscopic labral repair, SLAP, triple labrum, circumferential labrum, Pan-labral lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES score
Measured: 5 years
Secondary outcomes (4)
VAS pain
Measured: 5 yrs
Visual Analog Score Instability
Measured: 5 years
SANE score
Measured: 5 yrs
SF-12 score
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJan 2003
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society of Military Orthopedic Surgeons
- Sponsor type
- Research network
- Investigators
- John M Tokish, MD, Principal investigator, Society of Military Orthopedic Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849927
- Sponsor's protocol ID
- somos 12-04-01
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15689868
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00849927
- Acronym / sponsor ID
- somos 12-04-01
- Conditions
- Shoulder Instability
- Keywords
- shoulder instability, labral lesions, arthroscopic labral repair, SLAP, triple labrum, circumferential labrum, Pan-labral lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Society of Military Orthopedic SurgeonsResearch network
- Study start
- Jan 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient Demographics A total of 41 shoulders (34 men, 5 women) with mean age of 25.1 years (range, 17 to 38 years) were prospectively enrolled. 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). Thirty-seven of 39 patients were right handed. The dominant shoulder was affected in 30 shoulders, non-dominant in 11. Every patient had a primary chief complaint of shoulder pain with a history of anterior and/or posterior shoulder instability. All had a traumatic onset of their symptoms, twelve as a result of contact sports and had failed initial non-operative management. Two patients had had a previous operation, including one patient with a previous open Bankart, 4 years prior to index operation, and another that had a previous posterior arthroscopic "labral repair" which subsequently sustained an anterior dislocation. This was revised with open inferior capsular shift, 2 years prior to index operation. Twenty-six shoulders presented with clear evidence of primary anterior instability. These patients clearly remembered the initial dislocation event and demonstrating an abducted-externally rotated arm at the time of dislocation. Twenty-four of these patients also had pre-reduction radiographs showing anterior dislocation. An additional five patients in the group had variable levels of glenoid bone loss (5-10%), with small Hill-Sachs injuries. Nine shoulders had clear evidence of posterior instability as evidenced by these patients clearly remembering their initial dislocation event, and demonstrating a forward flexed, adducted, and internally rotated position of the arm at the time of dislocation. The remaining six shoulders could not discern between anterior or posterior instability as a primary direction.
All physical examinations were performed by the treating orthopedic surgeon. All shoulders were compared to the contralateral side for range of motion, strength, tenderness, and provocative maneuvers. Range of motion was examined in forward flexion, abduction, and external and internal rotation at 00 and 90 0 of abduction. As part of our normal protocol, values not significantly different from the contralateral side were recorded as "normal". Any value noted to be abnormal was to be recorded in degrees, or in the case of internal rotation at 00, the spinal level. On physical examination no patient was noted to have a significant loss of active or passive motion in flexion, abduction, internal rotation, or external rotation at 00. Thirty-nine of the 41 shoulders demonstrated a positive apprehension sign20, and thus arms were not taken to maximum external rotation in the abducted position in these patients. Strength testing was accomplished with manual muscle testing compared to the opposite arm in all 39 patients. Specific testing included shoulder abduction, internal and external rotation at 00, resisted scaption, lift-off and belly press testing20, as well as elbow flexion and extension, wrist flexion and extension, and interosseous muscle testing. No significant deficit was noted in any of these positions. All patients had pain induced limitation of strength testing during an active compression test20. Provocative maneuvers included anterior and posterior load and shift testing, an anterior apprehension test, a push-pull test for posterior instability, and an active compression test20 . Thirty-nine of 41 shoulders had a positive apprehension test20. Care was taken to place the patient with their arm in 90 degrees of abduction and increasing external rotation. Patients were asked to discern when they became symptomatic, and then asked whether the shoulder felt like it was "coming out" or if their symptoms were just pain. A positive apprehension test was defined as a sensation of the former. All 39 patients had a positive push-pull test for posterior laxity 20and pain. This test is performed by placing the patient supine on the examining table with the arm placed in 90 degrees of abduction and neutral rotation. The wrist is grasped and "pulled" by the examiner with one hand, while the other hand is used to "push" the shoulder backward. A positive test is signified by subluxation of the joint with a reproduction of the patient's symptoms. Impingement signs including Neer's sign, Hawkin's sign, and painful arc were performed on all 39 patients 20. At least one of the signs was positive in all patients. An active compression test was performed on all 39 patients, and noted to be positive with pain and weakness in all patients. No patient demonstrated an increased sulcus sign, or any sign of hyperlaxity.
MRIs were obtained in all 41 shoulders and all radiologic reports were reviewed. Thirty of 41 of these MRI's were done in conjunction with a gadolinium contrast arthrogram. Intraoperatively, all patients underwent an examination under anesthesia with particular attention directed toward anterior and posterior laxity examinations compared to the opposite side according to the grading system for instability established by the American Shoulder and Elbow Surgeons 21,22. Inferior laxity was measured by a sulcus sign measured in centimeters from the edge of the acromion to the top of the humeral head. At arthroscopy, all patients demonstrated complete circumferential tear of the glenoid labrum. One patient had an additional complete radial split of the labrum at the 1 o'clock position (anteriorly), which was repaired. The average patient had 7.1 anchors placed (range, 6-9). Post-operative examination while still under anesthesia showed restoration of normal anterior and posterior glenohumeral translation "to the rim".
Post-operatively, patients were seen at 2 weeks, 6 weeks, and 3 months, 6 months, one year, and yearly after that. History was taken with particular attention to recurrence of dislocation or feelings of apprehension or pain. Physical examination beginning at 3 months assessed range of motion, anterior apprehension, and posterior reproduction of symptoms using a push-pull test20. In addition, strength testing was accomplished, as was an active compression test. Patient outcomes were re-accomplished for the SANE, modified ASES and SF-12 visits at each follow-up visit beginning at 6 weeks. In addition, each patient was asked if he or she would undergo the surgery again. All surveys were administered using a standard form, and entered into the SOMOS database. Data was combined among surgeons using de-identified patient data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Department of Defense active duty members
Key inclusion criteria (2 listed)
- Surgical documentation of Pan Labral Lesion of shoulder
- Pre-operative documentation of outcomes scores
Key exclusion criteria (2 listed)
- lacking a Pan labral lesion
- other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ASES score
Time frame: 5 years
4 secondary outcomes
VAS pain
Time frame: 5 yrs
Visual Analog Score Instability
Time frame: 5 years
SANE score
Time frame: 5 yrs
SF-12 score
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
- Results publication: PubMed 15689868Lo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Tokish, MD principal investigator
Society of Military Orthopedic Surgeons
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Instability, run by Society of Military Orthopedic Surgeons at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009.