Subscapularis Repair Augmentation for Total Shoulder Arthroplasty
ConditionShoulder Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Total Shoulder Arthroplasty
Disqualifiers
Vulnerable population
Trial design
Design model
Parallel
Treatments tested in this trial
BioBrace Augmentation
DeviceDuring shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.
Standard Repair with Sutures
Procedure/SurgeryDuring shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: BioBrace AugmentationExperimental treatment 1 intervention
Group B: Standard Repair with SuturesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in continuity of subscapularis tissue on ultrasound
Continuity of subscapularis tissue on ultrasound
Time frame
6 weeks, 6 months after surgery2
Difference in thickness of the subscapularis tissue on ultrasound
Thickness of subscapularis tissue on ultrasound
Time frame
3 months, 1 years after surgery3
Evaluate arthritis on shoulder x-ray
Amount of arthritis or wear patterns on shoulder x-Ray
Time frame
Surgery4
Difference in signs of loosening or wear patterns in shoulder X-Ray
Signs of loosening or wear patterns on shoulder x-ray
Time frame
2 weeks, 3 months, 6 months, 1 year, 2 years after surgerySecondary outcomes
1
American Shoulder & Elbow Surgeons Score (ASES) score
is a 100-point scale that consists of two dimensions: pain and activities of daily living. 0 indicates worse shoulder condition and 100 indicates best shoulder condition. The greater the score, the lower the level of shoulder disability
Time frame
2 weeks, 3 months, 6 months, 1 year, 2 years after surgery2
Shoulder examination for the difference in Passive Range of Motion
Examining passive range of motion - forward flexion, external rotation, abduction
Time frame
2 weeks, 3 months, 6 months, 1 year, 2 years after surgery3
Shoulder examination for the difference in Active Range of Motion
Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press
Time frame
3 months, 6 months, 1 year, 2 years after surgerySponsors and contacts
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Source ClinicalTrials.gov