A Prospective multicenter study to examine the influence of repairing the sub-scapularis on outcomes after reverse arthroplasty: A randomized controlled trial.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Severe Arthropathy With A Grossly Deficient Rotator Cuff.
  • Age: Between 21 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
    2. Participants' sub scapularis has been determined from MRI to be sufficient to repair
    3. Those willing and able to comply with the study schedule and assessments
    4. Participants likely to be available for evaluation for the duration of the study
    5. Participants willing and able to provide written informed consent

You may not be eligible for this study if the following are true:

    1. Participants indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
    2. Has metal allergies or sensitivity
    3. Has active infection at or near the site of implantation
    4. Participants with nonfunctional deltoid muscle
    5. Participants with a neuromuscular compromise condition of the shoulder
    6. Has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
    7. Currently on or planning to be on chemotherapy or radiation or had chemotherapy or radiation within the last 6 months
    8. Currently taking > 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
    9. Pregnant or planning to become pregnant withint the study period
    10. Unable to understand the study or be compliant with the follow up or has a history of non-compliance with medical advice, in the investigator's opinion
    11. History of any cognitive or mental health status that would interfere with study participation
    12. Participants abusing alcohol or drugs or is undergoing active treatment for substance abuse



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