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

NCT ID: NCT02318381

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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 .

Conditions

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Entrapment Neuropathy Rotator Cuff Tear

Keywords

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suprascapular nerve rotator cuff tear suprascapular neuropathy superior transverse scapular ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Dissection of the superior transverse scapular ligament

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Platon Sachinis

Dr Nikolaos Platon Sachinis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolaos P Sachinis, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Orthopaedic Department of Aristotle University of Thessaloniki

Pericles Papadopoulos, Ph.D.

Role: STUDY_CHAIR

First Orthopaedic Department of Aristotle University of Thessaloniki

Sotirios Papagianopoulos, Ph.D.

Role: STUDY_DIRECTOR

Ī¤hird Neurology Department of Aristotle University of Thessaloniki

Ioannis Sarris, Ph.D.

Role: STUDY_DIRECTOR

Third Orthopaedic Department of Aristotle University of Thessaloniki

Locations

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

Thessaloniki, Exohi, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type RESULT
PMID: 24090983 (View on PubMed)

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.

Reference Type RESULT
PMID: 17986401 (View on PubMed)

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.

Reference Type RESULT
PMID: 17210425 (View on PubMed)

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.

Reference Type RESULT
PMID: 14564276 (View on PubMed)

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.

Reference Type RESULT
PMID: 12851579 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34156877 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27876086 (View on PubMed)

Other Identifiers

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NSachinisPhD1

Identifier Type: -

Identifier Source: org_study_id