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

Rotator Cuff Tear Clinical Trial

— SupraCufTear  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318381
• Other study ID #: NSachinisPhD1
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Entrapment Neuropathy
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Peripheral Nervous System Diseases
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• Dissection 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.

Locations

Country	Name	City	State
Greece	First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital	Thessaloniki	Exohi

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Albritton MJ, Graham RD, Richards RS 2nd, Basamania CJ. An anatomic study of the effects on the suprascapular nerve due to retraction of the supraspinatus muscle after a rotator cuff tear. J Shoulder Elbow Surg. 2003 Sep-Oct;12(5):497-500. — View Citation

Collin P, Treseder T, Lädermann A, Benkalfate T, Mourtada R, Courage O, Favard L. Neuropathy of the suprascapular nerve and massive rotator cuff tears: a prospective electromyographic study. J Shoulder Elbow Surg. 2014 Jan;23(1):28-34. doi: 10.1016/j.jse. — View Citation

Costouros JG, Porramatikul M, Lie DT, Warner JJ. Reversal of suprascapular neuropathy following arthroscopic repair of massive supraspinatus and infraspinatus rotator cuff tears. Arthroscopy. 2007 Nov;23(11):1152-61. — View Citation

Greiner A, Golser K, Wambacher M, Kralinger F, Sperner G. The course of the suprascapular nerve in the supraspinatus fossa and its vulnerability in muscle advancement. J Shoulder Elbow Surg. 2003 May-Jun;12(3):256-9. — View Citation

Lafosse L, Tomasi A, Corbett S, Baier G, Willems K, Gobezie R. Arthroscopic release of suprascapular nerve entrapment at the suprascapular notch: technique and preliminary results. Arthroscopy. 2007 Jan;23(1):34-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS).	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%.	Up to 6 weeks prior to surgery, at 6 months and at one year post-operatively.
Secondary	Size of rotator cuff tear	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.	Up to 6 weeks prior to surgery
Secondary	Changes of fatty infiltration of rotator cuff muscles	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	Up to 6 weeks prior to surgery, one year post-operatively.