Entrapment Neuropathy, Rotator Cuff Tear
Conditions
Keywords
suprascapular nerve, rotator cuff tear, suprascapular neuropathy, superior transverse scapular ligament
Brief summary
Aim of this prospective double blind randomized clinical trial is to understand the correlation of suprascapular neuropathy in the setting of large and massive tears of the shoulder rotator cuff and to investigate whether arthroscopic dissection of the superior transverse scapular ligament is positively related to the improvement of this neuropathy.
Detailed description
The suprascapular nerve originates from the upper trunk of the brachial plexus with participation from the A5 and A6 spinal nerve roots and occasionally from the A4 root. It is treading behind the clavicle and to the upper border of the scapula and then enters through the scapular notch of the shoulder and below the transverse superior transverse ligament to the rear surface of the scapula. This entry point is an important factor of pressure and surgical dissection of the ligament enlarges the space through which the nerve travels. The rotator cuff consists of the tendons of subscapularis, supraspinatus , infraspinatus and minor teres muscles. Cadaveric studies have shown that tears in the cuff , particularly massive ruptures a gap more than 5cm, change the path of the suprascapular nerve and create conditions that pressure. Until now, there are no prospective studies that compare the improvement of suprascapular neuropathy after arthroscopic dissection of the superior transverse scapular ligament in patients with rotator cuff tears , or that study the degree of neuropathy compared with the extent of the rupture .
Interventions
PROCEDUREDissection of the superior transverse scapular ligament
After treatment of the rotator cuff tear, the arthroscopic procedure will also proceed with the dissection of the superior transverse scapular ligament, in order to release pressure from the suprascapular nerve.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Large of Massive repairable rotator cuff tears combined suprascapular neuropathy
Exclusion criteria
* Suprascapular neuropathy of another cause (eg. brachial plexus neuropathy) * Other surgery at the same shoulder region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS). | Up to 6 weeks prior to surgery, at 6 months and at one year post-operatively. | Abnormal function of the suprascapular nerve in EMG studies will be indicated by fibrillation and high- frequency discharge potentials. An abnormal NCS finding is defined according to following values: infraspinatus latency \>4.5ms and amplitude \<8mV from peak to peak and supraspinatus muscle latency \>3.5 ms and an amplitude \<8 mV from peak to peak. The contralateral nerve will also be examined. Abnormal findings are also indicated when the difference in amplitude to the healthy side is \>50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size of rotator cuff tear | Up to 6 weeks prior to surgery | Size of rotator cuff tear will be measured in magnetic resonance tomography images, according to Cofield Classification of Rotator Cuff Tears (Cofield, Surg Gynec Obstet, 154(5): 667-672, 1982). Classification follows: Small tear \< 1cm, Medium 1-3 cm, Large 3-5 cm, Massive \>5cm. Diameter of the tear is measured. |
| Changes of fatty infiltration of rotator cuff muscles | Up to 6 weeks prior to surgery, one year post-operatively. | Fatty infiltration is assessed with magnetic resonance imaging studies, according to Goutallier's classification (Goutallier et al, CORR, 304:78-83, 1994). Classification follows: Stage 0 - Normal muscle, Stage 1 - Some fatty streaks, Stage 2 - Less than 50% fatty muscle atrophy, Stage 3 - 50% fatty muscle atrophy, Stage 4 - Greater than 50% fatty muscle atrophy |
Countries
Greece
Outcome results
None listed