Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression

Overview

The purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.

Full Title of Study: “Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: June 2024

Detailed Description

The suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. Retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function. This study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. Patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. They will be randomized into two arms: In one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. Post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.

Interventions

• Procedure: Rotator Cuff Repair without Suprascapular Nerve decompression
  • Traditional rotator cuff repair without Suprascapular nerve decompression
• Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression
  • Traditional rotator cuff repair with Suprascapular nerve decompression

Arms, Groups and Cohorts

• Active Comparator: Rotator cuff repair without Suprascapular Nerve decompression
  • approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention
• Active Comparator: Rotator Cuff Repair with Suprascapular Nerve decompression
  • approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention

Clinical Trial Outcome Measures

Primary Measures

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score
  • Time Frame: one year
  • The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.

Secondary Measures

• Constant Shoulder Score
  • Time Frame: one year
  • It includes pain score, functional assessment, range of motion and strength measures

Participating in This Clinical Trial

Inclusion Criteria

• Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction Exclusion Criteria:

• Patients less than 18 years of age – Irreparable rotator cuff tears

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Chicago
• Collaborator
  • NorthShore University HealthSystem
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Lewis L Shi, MD, Principal Investigator, University of Chicago
  • Jason Koh, MD, Principal Investigator, Northshore University