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

NCT ID: NCT03953339

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2019-02-18

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.

Conditions

Cuff Rotator Full Thickness Tear; Cuff Rotator Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

no release

no release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair

Group Type: ACTIVE_COMPARATOR

Release or no release of the suprascapular nerve

Intervention Type: PROCEDURE

release

arthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair

Group Type: EXPERIMENTAL

Release or no release of the suprascapular nerve

Intervention Type: PROCEDURE

Interventions

Release or no release of the suprascapular nerve

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

NeuroW514

Identifier Type: -

Identifier Source: org_study_id