Entrapment NeuropathySupraCufTearNCT02318381
Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment
A study testing Dissection of the superior transverse scapular ligament in people with Entrapment Neuropathy and Rotator Cuff Tear, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Entrapment Neuropathy, Rotator Cuff Tear
- What is being tested?
- Dissection of the superior transverse scapular ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Large of Massive repairable rotator cuff tears combined suprascapular neuropathy
Who cannot join
- Suprascapular neuropathy of another cause (eg. brachial plexus neuropathy)
- Other surgery at the same shoulder region
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Orthopaedic Department of Aristotle University of Thessaloniki, 'G. Papanikolaou' Hospital
Thessaloniki, Exohi, 57010
About this study
Official title: Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
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.
Read the 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 .
- Conditions
- Entrapment Neuropathy, Rotator Cuff Tear
- Being tested
- Dissection of the superior transverse scapular ligament
- Keywords
- suprascapular nerve, rotator cuff tear, suprascapular neuropathy, superior transverse scapular ligament
- Medical subject headings
- Charcot-Marie-Tooth Disease, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissection of the superior transverse scapular ligamentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Dissection of the superior transverse scapular ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 6 weeks prior to surgery, at 6 months and at one year post-operatively.
Secondary outcomes (2)
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.
Measured: Up to 6 weeks prior to surgery
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
Measured: Up to 6 weeks prior to surgery, one year post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Entrapment NeuropathyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Platon Sachinis, Aristotle University Of Thessaloniki
- Investigators
- Nikolaos P Sachinis, M.D., Principal investigator, First Orthopaedic Department of Aristotle University of ThessalonikiPericles Papadopoulos, Ph.D., Study chair, First Orthopaedic Department of Aristotle University of ThessalonikiSotirios Papagianopoulos, Ph.D., Study director, Τhird Neurology Department of Aristotle University of ThessalonikiIoannis Sarris, Ph.D., Study director, Third Orthopaedic Department of Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318381
- Sponsor's protocol ID
- NSachinisPhD1
- Acronym
- SupraCufTear
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2014
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24090983Costouros 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.
PubMed 17986401Lafosse 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.
PubMed 17210425Albritton 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.
PubMed 14564276Greiner 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.
PubMed 12851579Sachinis 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.
PubMed 34156877Sachinis 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.
PubMed 27876086
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Neuropathy in the Setting of Rotator Cuff Tears; Results of Arthroscopic Treatment
- ClinicalTrials.gov ID
- NCT02318381
- Acronym / sponsor ID
- SupraCufTear / NSachinisPhD1
- Conditions
- Entrapment Neuropathy, Rotator Cuff Tear
- Keywords
- suprascapular nerve, rotator cuff tear, suprascapular neuropathy, superior transverse scapular ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients with suprascapular neuropathy and rotator cuff tear treated arthroscopically without release of the superior transverse scapular ligament. |
| Ligament Release | Other | Procedure: Dissection of the superior transverse scapular ligamentPatients with suprascapular neuropathy and rotator cuff tear treated arthroscopically with release of the suprascapular nerve. Arthroscopic dissection of the superior transverse scapular ligament |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Large of Massive repairable rotator cuff tears combined suprascapular neuropathy
Key exclusion criteria (2 listed)
- Suprascapular neuropathy of another cause (eg. brachial plexus neuropathy)
- Other surgery at the same shoulder region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissection of the superior transverse scapular ligamentAfter 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. | Procedure or surgery | Ligament Release |
Primary outcome
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%.
2 secondary outcomes
Size of rotator cuff tear
Time frame: Up to 6 weeks prior to surgery
Changes of fatty infiltration of rotator cuff muscles
Time frame: Up to 6 weeks prior to surgery, one year post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Results publication: PubMed 24090983Collin 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 publication: PubMed 17986401Costouros 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 publication: PubMed 17210425Lafosse 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 publication: PubMed 14564276Albritton 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 publication: PubMed 12851579Greiner 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.
- Derived from this study: PubMed 34156877Sachinis 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.
- Derived from this study: PubMed 27876086Sachinis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos P Sachinis, M.D. principal investigator
First Orthopaedic Department of Aristotle University of Thessaloniki
Pericles Papadopoulos, Ph.D. study chair
First Orthopaedic Department of Aristotle University of Thessaloniki
Sotirios Papagianopoulos, Ph.D. study director
Τhird Neurology Department of Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissection of the superior transverse scapular ligament in people with Entrapment Neuropathy and Rotator Cuff Tear, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318381, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.