Novel Treatment for Rotator Cuff Tears
ConditionSupraspinatus Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasonic tenotomy
Procedure/SurgeryUltrasonic 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Repair a partially torn rotator cuffOther 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline, 2, 6, 12 and 24-weeks post-procedure2
Change in shoulder active range of motion
Measured using a goniometer reported in degrees
Time frame
Baseline, 2, 6, 12 and 24-weeks post-procedure3
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.
Time frame
Baseline, 2, 6, 12 and 24-weeks post-procedureSecondary outcomes
1
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.
Time frame
Baseline, 2, 6, 12 and 24-weeks post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov