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

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ClinicalTrials.gov Identifier: NCT02318381
Recruitment Status : Recruiting
First Posted : December 17, 2014
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nikolaos Platon Sachinis, 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.

Condition or disease Intervention/treatment Phase
Entrapment Neuropathy Rotator Cuff Tear Procedure: Dissection of the superior transverse scapular ligament Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
No Intervention: 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

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Size of rotator cuff tear [ Time Frame: 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.

  2. Changes of fatty infiltration of rotator cuff muscles [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318381


Contacts
Contact: Nikolaos P Sachinis, M.D. 00306978305195 nick.sachinis@gmail.com
Contact: Pericles Papadopoulos, Ph.D. 00306977353735 perpap@otenet.gr

Locations
Greece
First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital Recruiting
Thessaloniki, Exohi, Greece, 57010
Contact: Nikolaos P Sachinis, M.D.    00306978305195    nick.sachinis@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Nikolaos P Sachinis, M.D. First Orthopaedic Department of Aristotle University of Thessaloniki
Study Chair: Pericles Papadopoulos, Ph.D. First Orthopaedic Department of Aristotle University of Thessaloniki
Study Director: 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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nikolaos Platon Sachinis, Dr Nikolaos Platon Sachinis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02318381     History of Changes
Other Study ID Numbers: NSachinisPhD1
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Nikolaos Platon Sachinis, Aristotle University Of Thessaloniki:
suprascapular nerve
rotator cuff tear
suprascapular neuropathy
superior transverse scapular ligament

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Rotator Cuff Injuries
Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Neuromuscular Diseases
Nervous System Diseases
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn