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

NCT03953339 | Completed

• 1 other identifier: NeuroW514
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cuff Rotator Full Thickness Tear; Cuff Rotator Syndrome

Outcome Measures

Primary Outcomes (3)

• electromyographic assessment of suprascapular nerve function

  sharp waves, complex repetitive discharges and fasciculations in supra- and infraspinatus muscles. Presence or absence

  preoperatively, change from preoperatively to 3 months and change from 3 to 12 months

• electromyographic assessment of suprascapular nerve function

  motor latency to supra- and infraspinatus muscles milliseconds

  preoperatively, change from preoperatively to 3 months and change from 3 to 12 months

• electromyographic assessment of suprascapular nerve function

  conduction velocity (m/sec)

  preoperatively, change from preoperatively to 3 months and change from 3 to 12 months

Secondary Outcomes (3)

• Maximal daily pain on visual analog scale

  preoperatively and change from preoperatively to 3 months and change from 3 to 12 months

• Active range of motion

  preoperatively and change from preoperatively to 3 months and change from 3 to 12 months

• Strength

  preoperatively and change from preoperatively to 3 months and change from 3 to 12 months

Study Arms (2)

no release

ACTIVE COMPARATOR

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

Procedure: Release or no release of the suprascapular nerve

release

EXPERIMENTAL

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

Procedure: Release or no release of the suprascapular nerve

Interventions

Release or no release of the suprascapular nerve PROCEDURE

no release; release

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

University Hospital Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: May 16, 2019
• Study Start: January 1, 2014
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CH (1)