Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment

Not Applicable

Completed

• Conditions: Rotator Cuff Tear; Entrapment Neuropathy
• Interventions: Procedure: Dissection of the superior transverse scapular ligament

• Registration Number: NCT02318381
• Lead Sponsor: Aristotle University Of Thessaloniki

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Primary Completion: 2018-05
• Study Completion: 2018-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligament Release	Dissection of the superior transverse scapular ligament	Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically with release of the suprascapular nerve. Arthroscopic dissection of the superior transverse scapular ligament

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital; 🇬🇷 Thessaloniki, Exohi, Greece