Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS).
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically without release of the superior transverse scapular ligament.
Ligament Release
Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically with release of the suprascapular nerve.
Arthroscopic dissection of the superior transverse scapular ligament
Intervention: Dissection of the superior transverse scapular ligament (Procedure)
Outcomes
Primary Outcomes
Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS).
Time Frame: 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 Outcomes
- Size of rotator cuff tear(Up to 6 weeks prior to surgery)
- Changes of fatty infiltration of rotator cuff muscles(Up to 6 weeks prior to surgery, one year post-operatively.)
Investigators
Nikolaos Platon Sachinis
Dr Nikolaos Platon Sachinis
Aristotle University Of Thessaloniki