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

Primary Purpose

Entrapment Neuropathy, Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dissection of the superior transverse scapular ligament
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Entrapment Neuropathy focused on measuring suprascapular nerve, rotator cuff tear, suprascapular neuropathy, superior transverse scapular ligament

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control

Ligament Release

Arm Description

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.
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

Full Information

First Posted
December 5, 2014
Last Updated
December 26, 2018
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT02318381
Brief Title
Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment
Acronym
SupraCufTear
Official Title
Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Entrapment Neuropathy, Rotator Cuff Tear
Keywords
suprascapular nerve, rotator cuff tear, suprascapular neuropathy, superior transverse scapular ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically without release of the superior transverse scapular ligament.
Arm Title
Ligament Release
Arm Type
Other
Arm Description
Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically with release of the suprascapular nerve. Arthroscopic dissection of the superior transverse scapular ligament
Intervention Type
Procedure
Intervention Name(s)
Dissection of the superior transverse scapular ligament
Intervention Description
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 Measure Information:
Title
Changes of function of suprascapular nerve, assessed by electromyographic (EMG) and nerve conduction studies (NCS).
Description
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%.
Time Frame
Up to 6 weeks prior to surgery, at 6 months and at one year post-operatively.
Secondary Outcome Measure Information:
Title
Size of rotator cuff tear
Description
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.
Time Frame
Up to 6 weeks prior to surgery
Title
Changes of fatty infiltration of rotator cuff muscles
Description
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
Time Frame
Up to 6 weeks prior to surgery, one year post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos P Sachinis, M.D.
Organizational Affiliation
First Orthopaedic Department of Aristotle University of Thessaloniki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pericles Papadopoulos, Ph.D.
Organizational Affiliation
First Orthopaedic Department of Aristotle University of Thessaloniki
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sotirios Papagianopoulos, Ph.D.
Organizational Affiliation
Τhird Neurology Department of Aristotle University of Thessaloniki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ioannis Sarris, Ph.D.
Organizational Affiliation
Third Orthopaedic Department of Aristotle University of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital
City
Thessaloniki
State/Province
Exohi
ZIP/Postal Code
57010
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24090983
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.
Results Reference
result
PubMed Identifier
17986401
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.
Results Reference
result
PubMed Identifier
17210425
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.
Results Reference
result
PubMed Identifier
14564276
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.
Results Reference
result
PubMed Identifier
12851579
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.
Results Reference
result
PubMed Identifier
34156877
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.
Results Reference
derived
PubMed Identifier
27876086
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.
Results Reference
derived

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

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