The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject is ≥21 years of age
2. Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
3. Subject's sub scapularis has been determined from MRI to be sufficient to repair
4. Subject is willing and able to comply with the study schedule and assessments
5. Subject is likely to be available for evaluation for the duration of the study
6. Subject is willing and able to sign the informed consent
Exclusion Criteria:
1. Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
2. Subject has metal allergies or sensitivity
3. Subject has an active infection at or near the site of implantation
4. Subject has a nonfunctional deltoid muscle
5. Subject has neuromuscular compromise condition of the shoulder
6. Subject has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
7. Subject is currently on or planning to be on chemotherapy or radiation
8. Subject has had chemotherapy or radiation within the last 6 months
9. Subject is currently taking \> 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
10. Female subjects who are pregnant or planning to become pregnant within the study period
11. In the investigator's opinion, the subject is unable to understand the study or be compliant with the follow up or has a history of non-compliance with medical advice
12. Subject has a history of any cognitive or mental health status that would interfere with study participation
13. Subject is abusing alcohol or drugs or is undergoing active treatment for substance abuse (e.g., recreational drugs, narcotics, or alcohol).
Primary outcome measure(s)
Change in isometric and isokinetic internal rotational strength of abductors — 6 months, and 1, 2, 5 and 10 years Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of flexors — 6 months, and 1, 2, 5 and 10 years Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of internal rotators — 6 months, and 1, 2, 5 and 10 years Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of external rotators — 6 months, and 1, 2, 5 and 10 years Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge
Trial sites (4)
Facility
City
Region
Status
St. Luke's Hospital
St Louis
Missouri
NYU Langone Center for Musculoskeletal Care
New York
New York
Rothman Institute
Philadelphia
Pennsylvania
Texas Orthopedic Group
Houston
Texas
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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