Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01405781 |
| Other study ID # |
46622 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2011 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is twofold: First, to determine whether higher levels of
pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff
repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function,
Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically
examine and perform a radiographic analysis of patients at a minimum of 6 months after
reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic
scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator
cuff repair.
Description:
Clinical outcome studies have been performed in the evaluation of a variety of shoulder
pathologies after surgical treatment. Among these disease processes include glenohumeral
osteoarthritis, rotator cuff arthropathy, acromioclavicular separations and scapulothoracic
bursitis. A variety of outcomes studies have been performed on these pathologies although few
have utilized several functional outcome measures. Also with respect to each of these
diagnoses, several specific areas of research regarding outcomes assessment have not been
investigated.
Glenohumeral osteoarthritis is one of the most common shoulder pathologies treated by
orthopedic surgeons. For endstage osteoarthritis, an anatomic total shoulder arthroplasty
provides excellent pain relief and functional improvement. In order to perform the
replacement, the rotator cuff tendon in the front of the shoulder (subscapularis) needs to be
taken down and then repaired at the completion of the case. There are three basic methods of
takedown and repair: tenotomy, peel-off and lesser tuberosity osteotomy. The osteotomy has
been compared clinically to tenotomy and found to provide a lower rate of subscapularis
tears, higher outcome scores and universal healing evaluated using ultrasound and the PENN
shoulder score.1 Gerber et al has also evaluated long-term outcomes of total shoulder
arthroplasty with lesser osteotomy using the Constant score as a measure of outcomes.2
Unfortunately, many outcome studies evaluating total shoulder arthroplasty utilize the Simple
Shoulder Test and the American Shoulder and Elbow Surgeons (ASES) Score which have not been
evaluated. Also, osteotomy was performed only utilizing a "fleck" of bone instead of the
entire lesser tuberosity. No studies to date have evaluated TSA with an osteotomy of the
entire lesser tuberosity.
Reverse total shoulder arthroplasty has shown be a predictable operation for the treatment of
rotator cuff arthropathy with clinical improvements in both pain and function at long term.
3,4 Dislocation has been reported between 0% to 9% after reverse total shoulder arthroplasty
and has been defined as one of the top three most common complications associated with
reverse TSA.3-10 There is considerable debate regarding whether the subscapularis tendon
needs repair after reverse TSA. Edwards et al reported a statistically significant reduction
in dislocation rates from 9% to 0% with addition of subscapularis repair.10 These results had
significant bias with regards to randomization of patients. Similarly, all patients in the
non-repair group were at the initial portion of his learning curve. Consequently, the risk
for instability is likely lower than reported in his series.
Acromioclavicular joint separations represent one of the most common shoulder injuries
accounting for approximately 9% of shoulder girdle injuries.11 Acromioclavicular injuries
have been classified with increasing severity from I to VI based upon disruption of the
various ligamentous and muscular supports including the acromioclavicular ligaments,
coracoclavicular ligaments and deltotrapezial fascia.12 Recommended initial treatment for
grade I to III injuries has been nonoperative with reasonable clinical results while initial
surgical stabilization has been recommended for higher grade injuries.12-15
A variety of surgical stabilization techniques for acromioclavicular joint separations have
been reported including the transfer of the coracoacromial ligament from the acromion to the
end of the resected distal clavicle originally described by Weaver and Dunn in 1972.16 A
modification of the Weaver-Dunn acromioclavicular reconstruction was subsequently described
which included coracoclavicular stabilization with nonabsorbable suture.17 Despite this
modification, residual subluxation or dislocation of the acromioclavicular joint has been
identified in up to 29% of patients.17 Consequently, alternative constructs have been
described including an anatomic reconstruction utilizing a tendon graft which has been shown
to have superior biomechanical strength compared to a Weaver-Dunn reconstruction.18
As part of the surgical transition from the modified Weaver-Dunn reconstruction as described
by Weinstein et al. to a reconstruction using a tendon graft, augmentation of the
coracoclavicular suture fixation with either allograft or autograft tendon as well as
performing the coracoacromial ligament transfer has been described.17,19 This differs from
the anatomic reconstruction described by Mazzocca et al., as it includes both the transferred
coracoacromial ligament and the hamstring graft for stabilization instead of just the
graft.11 Coracoclavicular ligament reconstruction with a tendon graft has been reported as a
treatment option for failed Weaver-Dunn reconstructions.20,21 Possible benefits of the
combined reconstruction include improved construct strength and a vascularized ligament.
Drawbacks include increased surgical dissection, increased operating room time and disruption
of the coracoacromial arch. With the advances in arthroscopic techniques, acromioclavicular
reconstructions utilizing a tendon graft are now being performed arthroscopically which has
been described without the addition of coracoacromial ligament transfer.22 Reconstructions
without coracoacromial ligament transfers may increase the ease of performing a
reconstruction through smaller incisions with arthroscopic assistance. No study has evaluated
the clinical effects of adding a coracoacromial ligament transfer to an acromioclavicular
joint reconstruction utilizing a coracoclavicular tendon graft.
Scapulothoracic bursitis or "snapping scapula syndrome" is an under-recognized shoulder
disorder where the bursal sac between the scapula and chest wall becomes irritated and
inflamed. The etiology is overuse causing reactive bursa formation between the scapula and
thorax. If conservative measures fail as initial attempts at management, surgical excision of
the inflamed bursa with resection of the superior medial angle of the scapula can be
performed. The procedure can be performed either arthroscopically or open. A two-portal or
three-portal technique can be utilized if performed arthroscopically. Very limited data
exists regarding outcomes of two-portal or three-portal techniques with no use of validated
patient-based outcome scores.23,24
Rotator cuff tearing is the most common shoulder pathology treated by orthopedic surgeons.
Healing rates after rotator cuff repair have varied in the literature from less than 5% to
100% dependent on tear size, age, repair construct and muscle quality.25,26 A variety of
methods have been used to repair the tendon. A recent biomechanical study has shown that
repair with triple-loaded suture anchors have improved initial biomechanical properties
compared to other constructs.27 No clinical data exists on healing after repair with triple
loaded anchors or how healing effects function.
