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

NCT02318381 | Completed

• 1 other identifier: NSachinisPhD1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Entrapment Neuropathy; Rotator Cuff Tear

Keywords

suprascapular nerve; rotator cuff tear; suprascapular neuropathy; superior transverse scapular ligament

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Control

NO INTERVENTION

Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically without release of the superior transverse scapular ligament.

Ligament Release

OTHER

Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically with release of the suprascapular nerve. Arthroscopic dissection of the superior transverse scapular ligament

Procedure: Dissection of the superior transverse scapular ligament

Interventions

Dissection of the superior transverse scapular ligament PROCEDURE

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.

Ligament Release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Large of Massive repairable rotator cuff tears combined suprascapular neuropathy

You may not qualify if:

• Suprascapular neuropathy of another cause (eg. brachial plexus neuropathy)
• Other surgery at the same shoulder region

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital

Thessaloniki, Exohi, 57010, Greece

Location

Related Publications (7)

• 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.

  PMID: 24090983 RESULT

• 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.

  PMID: 17986401 RESULT

• 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.

  PMID: 17210425 RESULT

• 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.

  PMID: 14564276 RESULT

• 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.

  PMID: 12851579 RESULT

• 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.

  PMID: 34156877 DERIVED

• 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.

  PMID: 27876086 DERIVED

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Nikolaos P Sachinis, M.D.

  First Orthopaedic Department of Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Pericles Papadopoulos, Ph.D.

  First Orthopaedic Department of Aristotle University of Thessaloniki

  STUDY CHAIR

• Sotirios Papagianopoulos, Ph.D.

  Τhird Neurology Department of Aristotle University of Thessaloniki

  STUDY DIRECTOR

• Ioannis Sarris, Ph.D.

  Third Orthopaedic Department of Aristotle University of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Nikolaos Platon Sachinis

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

GR (1)