Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00849927 |
| Other study ID # |
somos 12-04-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 18, 2009 |
| Last updated |
February 21, 2009 |
| Start date |
January 2003 |
| Est. completion date |
August 2008 |
Study information
| Verified date |
February 2009 |
| Source |
Society of Military Orthopedic Surgeons |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical 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.
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.
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.
