The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty
Enrolling by invitation · Not applicable
Conditions studied: Severe Arthropathy With a Grossly Deficient Rotator Cuff
In brief
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.
Key facts
- Study ID
- NCT03711175
- Run by
- Encore Medical, L.P.
- People needed
- 200
- Starts
- 2018-09-28
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2022-03-22
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is ≥21 years of age
- 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
- Subject's sub scapularis has been determined from MRI to be sufficient to repair
- Subject is willing and able to comply with the study schedule and assessments
- Subject is likely to be available for evaluation for the duration of the study
- Subject is willing and able to sign the informed consent
You may not qualify if…
- Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
- Subject has metal allergies or sensitivity
- Subject has an active infection at or near the site of implantation
- Subject has a nonfunctional deltoid muscle
- Subject has neuromuscular compromise condition of the shoulder
- Subject has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
- Subject is currently on or planning to be on chemotherapy or radiation
- Subject has had chemotherapy or radiation within the last 6 months
- Subject is currently taking > 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
- Female subjects who are pregnant or planning to become pregnant within the study period
- 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
- Subject has a history of any cognitive or mental health status that would interfere with study participation
- Subject is abusing alcohol or drugs or is undergoing active treatment for substance abuse (e.g., recreational drugs, narcotics, or alcohol).
Where it is running
- St. Luke's Hospital — St Louis, Missouri, United States
- NYU Langone Center for Musculoskeletal Care — New York, New York, United States
- Rothman Institute — Philadelphia, Pennsylvania, United States
- Texas Orthopedic Group — Houston, Texas, United States
Full record on ClinicalTrials.gov
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