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
|Condition or disease||Intervention/treatment||Phase|
|Entrapment Neuropathy Rotator Cuff Tear||Procedure: Dissection of the superior transverse scapular ligament||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
No Intervention: Control
Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically without release 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
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.
- 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%.
- 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.
- 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
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
|Contact: Nikolaos P Sachinis, M.D.||firstname.lastname@example.org|
|Contact: Pericles Papadopoulos, Ph.D.||email@example.com|
|First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital||Recruiting|
|Thessaloniki, Exohi, Greece, 57010|
|Contact: Nikolaos P Sachinis, M.D. 00306978305195 firstname.lastname@example.org|
|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|