Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff

Not Applicable

Completed

• Conditions: Cuff Rotator Syndrome; Cuff Rotator Full Thickness Tear
• Interventions: Procedure: Release or no release of the suprascapular nerve

• Registration Number: NCT03953339
• Lead Sponsor: Balgrist University Hospital

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.

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2017-06-29
• Primary Completion: 2019-02-18
• Study Completion: 2019-02-18
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Informed Consent
• MRI diagnosis of partial or full thickness rotator cuff tear

Exclusion Criteria

• Previous surgery
• Fatty muscle infiltration Goutallier stages III and IV
• Diabetes mellitus
• pregnancy
• unwillingness or contraindications for Magnetic resonance imaging
• unwillingness or contraindications to electrophysiological assessment
• substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
release	Release or no release of the suprascapular nerve	arthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair
no release	Release or no release of the suprascapular nerve	no release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair

Primary Outcome Measures

Name	Time	Method
electromyographic assessment of suprascapular nerve function	preoperatively, change from preoperatively to 3 months and change from 3 to 12 months	conduction velocity (m/sec)

Secondary Outcome Measures

Name	Time	Method
Maximal daily pain on visual analog scale	preoperatively and change from preoperatively to 3 months and change from 3 to 12 months	Measurement of pain using a visual analog scale 100 points maximal imaginable pain; 0 no pain
Active range of motion	preoperatively and change from preoperatively to 3 months and change from 3 to 12 months	Measurement of active elevation, abduction external and internal rotation in degrees measured with a handheld goniometer.
Strength	preoperatively and change from preoperatively to 3 months and change from 3 to 12 months	Isometric measurement of strength of shoulder abduction in pounds (1 pound represents 1 point in the scoring system)using a validated dynamometer

Trial Locations

Locations (1)

University Hospital Balgrist; 🇨🇭 Zurich, Switzerland