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Novel Treatment for Rotator Cuff Tears

Primary Purpose

Supraspinatus Tear

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasonic tenotomy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraspinatus Tear focused on measuring Ultrasonic tenotomy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI.

Exclusion Criteria:

  • A tear of the supraspinatus tendon greater > 50% and any areas of full thickness tearing, concomitant tears > 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum.
  • Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period.
  • Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder.
  • Previous corticosteroid injection within three months.
  • Those individuals less than 25 and greater than 75 years of age will be excluded.

Sites / Locations

  • Mayo Clinic Health System - OnalaskaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Repair a partially torn rotator cuff

Arm Description

Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated

Outcomes

Primary Outcome Measures

Change in pain
Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)
Change in shoulder active range of motion
Measured using a goniometer reported in degrees
Change in shoulder strength
Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.

Secondary Outcome Measures

Change in quality of life
Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.

Full Information

First Posted
October 19, 2022
Last Updated
December 13, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05590494
Brief Title
Novel Treatment for Rotator Cuff Tears
Official Title
Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (<50%) of the supraspinatus tendon of the rotator cuff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Tear
Keywords
Ultrasonic tenotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repair a partially torn rotator cuff
Arm Type
Other
Arm Description
Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic tenotomy
Intervention Description
Ultrasonic procedure as part of standard of care, as clinically indicated, to stimulate healing of the partial tear. The procedure uses ultrasound guidance that allows a needlelike device to gradually break up and remove tendinopathic tendon tissue.
Primary Outcome Measure Information:
Title
Change in pain
Description
Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)
Time Frame
Baseline, 2, 6, 12 and 24-weeks post-procedure
Title
Change in shoulder active range of motion
Description
Measured using a goniometer reported in degrees
Time Frame
Baseline, 2, 6, 12 and 24-weeks post-procedure
Title
Change in shoulder strength
Description
Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.
Time Frame
Baseline, 2, 6, 12 and 24-weeks post-procedure
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.
Time Frame
Baseline, 2, 6, 12 and 24-weeks post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI. Exclusion Criteria: A tear of the supraspinatus tendon greater > 50% and any areas of full thickness tearing, concomitant tears > 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum. Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period. Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder. Previous corticosteroid injection within three months. Those individuals less than 25 and greater than 75 years of age will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Erickson, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System - Onalaska
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Erickson, DO
Phone
608-392-9876
Email
erickson.jacob@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Novel Treatment for Rotator Cuff Tears

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