Tuberoplasty Versus Balloon Spacer
ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Minnesota
About this trial
The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.
No involvement of the subscapularis.
Centered humeral head on X-ray examination.
Primary complaint of pain.
Disqualifiers
Involvement of the subscapularis.
Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.
Rotator cuff deemed repairable at the time of surgery.
Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65
Trial design
Design model
Parallel
Treatments tested in this trial
biologic tuberoplasty
Procedure/Surgerya surgical procedure during which an a cellular dermal allograft is attached to the greater tuberosity to prevent bone-to-bone contact between the greater tuberosity and the acromion with the goal of decreasing pain
subacromial balloon spacer
Procedure/Surgerya biodegradable balloon is inserted into the subacromial space of the shoulder to increase teh distance between the greater tuberosity and the acromion to reduce pain
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: biologic tuberoplasty groupExperimental treatment 1 intervention
Group B: subacromial balloon spacer groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in bone-to-bone contact between tuberosity and acromion
degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy
Time frame
presurgery, 6 months postop, 12 months postop2
shoulder range of motion
quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation
Time frame
presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively3
single assessment numerical evaluation (SANE) of the shoulder
a validated tool providing a numerical score from 0-100 that assess shoulder function as subjectively reported by the subject. A higher score indicates superior shoulder function.
Time frame
presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively4
American shoulder and elbow surgeons (ASES) score
a validated survey with possible scores from 0-100 that assesses shoulder function as reported by the subject. A higher score indicates superior shoulder function.
Time frame
presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov