Clinical trial NCT02318381: Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment
Official title: Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Entrapment Neuropathy
Rotator Cuff Tear
Keywords: suprascapular nerve
rotator cuff tear
suprascapular neuropathy
superior transverse scapular ligament
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS).
timeFrame: Up to 6 weeks prior to surgery, at 6 months and at one year post-operatively.
Secondary outcomes:
measure: Size of rotator cuff tear
timeFrame: Up to 6 weeks prior to surgery
measure: Changes of fatty infiltration of rotator cuff muscles
timeFrame: Up to 6 weeks prior to surgery, one year post-operatively.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital
state: Exohi
Study officials:
affiliation: First Orthopaedic Department of Aristotle University of Thessaloniki
name: Nikolaos P Sachinis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Orthopaedic Department of Aristotle University of Thessaloniki
name: Pericles Papadopoulos, Ph.D.
role: STUDY_CHAIR
affiliation: Τhird Neurology Department of Aristotle University of Thessaloniki
name: Sotirios Papagianopoulos, Ph.D.
role: STUDY_DIRECTOR
affiliation: Third Orthopaedic Department of Aristotle University of Thessaloniki
name: Ioannis Sarris, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Collin P, Treseder T, Ladermann 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.2013.07.039. Epub 2013 Sep 30.
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. doi: 10.1016/j.arthro.2007.06.014.
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. doi: 10.1016/j.arthro.2006.10.003.
citation: 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. doi: 10.1016/s1058-2746(03)00182-4.
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. doi: 10.1016/s1058-2746(02)00034-4.
citation: Sachinis NP, Papagiannopoulos S, Sarris I, Papadopoulos P. Outcomes of Arthroscopic Nerve Release in Patients Treated for Large or Massive Rotator Cuff Tears and Associated Suprascapular Neuropathy: A Prospective, Randomized, Double-Blinded Clinical Trial. Am J Sports Med. 2021 Jul;49(9):2301-2308. doi: 10.1177/03635465211021834. Epub 2021 Jun 22.
citation: Sachinis NP, Boutsiadis A, Papagiannopoulos S, Ditsios K, Christodoulou A, Papadopoulos P. Suprascapular neuropathy in the setting of rotator cuff tears: study protocol for a double-blinded randomized controlled trial. Trials. 2016 Nov 22;17(1):554. doi: 10.1186/s13063-016-1672-y.