The suprascapular nerve innervates the musculi supra- and infraspinatus, which, as part of the rotator cuff, allow lifting and external rotation in the shoulder joint. Damage to this nerve can lead to pain and functional deficit. Causes of injury are compression by bony / ligamentous anomalies, fracture sequelae and traction damage. In the literature, a (often subclinical) traction damage is increasingly claimed by a muscle retraction after rupture of the supra- and / or infraspinatus tendon as a cause of pain and functional disturbances. The retraction of the ruptured tendon-muscular unit is said to lead to traction damage of the nerve, which can be demonstrated by pathological EMG derivations. By repositioning the tendon to its outbreak site, the nerve is occasionally overstretched, so that individual authors propagate a routine nerve decompression as prophylaxis. In individual cases, a previously pathologic EMG result could be improved after reconstitution of an rotator cuff rupture. However, prospective studies are not available.
It is not known how often a nerve damage is present before a rotator cuff operation and it is not known how often the tendon repair leads to nerve damage or recovery of damage. It is not known whether the surgical nerve decompression is associated with reduced postoperative pain and what a profit or what risks bring about a routine decompression of the nerve to the patient. To answer this question, this prospective randomized study is to be carried out.
Condition or disease | Intervention/treatment | Phase |
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Cuff Rotator Full Thickness Tear Cuff Rotator Syndrome | Procedure: Release or no release of the suprascapular nerve | Not Applicable |
On the basis of preoperative electromyography (EMG) and electroneurography (ENG), the investigators would like to determine the frequency of suprascapular neuropathy in ruptures of supra- and / or infraspinatus tendons and the risk factors for their presence.
In a ruptured rotator cuff, the muscle is partly retracted so much that the innervating nerve (suprascapular nerve) is stretched and has pathological neurological findings. The Investigators now want to analyze how the arthroscopic reconstruction of the nasal suprascapular nerve affects the pre-operative neuropathy. Does the pre-existing nerve recover by decompression (liberation) from surrounding / entangling tissue or does decompression have no influence on measurable neurology? Other patients with rotator cuff ruptures have normal neurological findings preoperatively despite severe retraction of the muscular / tendon unit. In these cases, the investigators are interested in whether the mobilization and reconstruction of the torn muscle / tendon unit leads to a neurologically measurable elongation of the nerve. This nerve stretching is a possible explanation for protracted postoperative pain. With the postoperative electrophysiological measurements we can quantify this nerve change.
The comparison between preoperative and postoperative neurology findings allows confirmation or refutation of our hypothesis.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff |
Actual Study Start Date : | January 1, 2014 |
Actual Primary Completion Date : | February 18, 2019 |
Actual Study Completion Date : | February 18, 2019 |
Arm | Intervention/treatment |
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Active Comparator: no release
no release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair
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Procedure: Release or no release of the suprascapular nerve |
Experimental: release
arthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair
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Procedure: Release or no release of the suprascapular nerve |
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
University Hospital Balgrist | |
Zurich, Switzerland, 8008 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 29, 2017 | ||||
First Posted Date ICMJE | May 16, 2019 | ||||
Last Update Posted Date | May 16, 2019 | ||||
Actual Study Start Date ICMJE | January 1, 2014 | ||||
Actual Primary Completion Date | February 18, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff | ||||
Official Title ICMJE | Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff | ||||
Brief Summary |
The suprascapular nerve innervates the musculi supra- and infraspinatus, which, as part of the rotator cuff, allow lifting and external rotation in the shoulder joint. Damage to this nerve can lead to pain and functional deficit. Causes of injury are compression by bony / ligamentous anomalies, fracture sequelae and traction damage. In the literature, a (often subclinical) traction damage is increasingly claimed by a muscle retraction after rupture of the supra- and / or infraspinatus tendon as a cause of pain and functional disturbances. The retraction of the ruptured tendon-muscular unit is said to lead to traction damage of the nerve, which can be demonstrated by pathological EMG derivations. By repositioning the tendon to its outbreak site, the nerve is occasionally overstretched, so that individual authors propagate a routine nerve decompression as prophylaxis. In individual cases, a previously pathologic EMG result could be improved after reconstitution of an rotator cuff rupture. However, prospective studies are not available. It is not known how often a nerve damage is present before a rotator cuff operation and it is not known how often the tendon repair leads to nerve damage or recovery of damage. It is not known whether the surgical nerve decompression is associated with reduced postoperative pain and what a profit or what risks bring about a routine decompression of the nerve to the patient. To answer this question, this prospective randomized study is to be carried out. |
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Detailed Description |
On the basis of preoperative electromyography (EMG) and electroneurography (ENG), the investigators would like to determine the frequency of suprascapular neuropathy in ruptures of supra- and / or infraspinatus tendons and the risk factors for their presence. In a ruptured rotator cuff, the muscle is partly retracted so much that the innervating nerve (suprascapular nerve) is stretched and has pathological neurological findings. The Investigators now want to analyze how the arthroscopic reconstruction of the nasal suprascapular nerve affects the pre-operative neuropathy. Does the pre-existing nerve recover by decompression (liberation) from surrounding / entangling tissue or does decompression have no influence on measurable neurology? Other patients with rotator cuff ruptures have normal neurological findings preoperatively despite severe retraction of the muscular / tendon unit. In these cases, the investigators are interested in whether the mobilization and reconstruction of the torn muscle / tendon unit leads to a neurologically measurable elongation of the nerve. This nerve stretching is a possible explanation for protracted postoperative pain. With the postoperative electrophysiological measurements we can quantify this nerve change. The comparison between preoperative and postoperative neurology findings allows confirmation or refutation of our hypothesis. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Release or no release of the suprascapular nerve | ||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
20 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 18, 2019 | ||||
Actual Primary Completion Date | February 18, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Switzerland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03953339 | ||||
Other Study ID Numbers ICMJE | NeuroW514 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Balgrist University Hospital | ||||
Study Sponsor ICMJE | Balgrist University Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Balgrist University Hospital | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |