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Clinical Trials in the USA / NCT03711175
Enrolling by invitation Not applicable

The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty

NCT03711175 · tracked via the Priya Life Science USA tracker
Sponsor
Encore Medical, L.P.
Phase
Not applicable
Started
2018-09-28
Last updated
2022-03-22

Condition(s) studied

Severe Arthropathy With a Grossly Deficient Rotator Cuff

Investigational drug(s) / intervention(s)

Subscapularis repairShoulder implant

Subscapularis repair: Utilizing fiberwire, high tensile strength suture

Shoulder implant: Reverse shoulder arthroplasty device

Study summary

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)

Trial sites (4)

FacilityCityRegionStatus
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.

View NCT03711175 on ClinicalTrials.gov ↗ ← All trials in the USA