Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty

Last updated: February 26, 2025
Sponsor: Exactech
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05615259
CR18-004
  • Ages > 21
  • All Genders

Study Summary

The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques. The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes. Long-term follow-up to 10 years with minimum 2 year follow-up for patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is at least 21 years of age at the time of surgery

  • Patient is indicated for reverse shoulder arthroplasty

  • Patient is willing to participate by complying with pre- and postoperative visitrequirements

  • Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)

  • Patient is willing and able to review and sign a study informed consent form

  • Preop CT scan is within 3 months of the date of surgery

Exclusion

Exclusion Criteria:

  • Revision shoulder arthroplasty

  • Reverse shoulder arthroplasty for fracture

  • Need for structural glenoid bone graft

  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or asecondary remote infection is suspected or confirmed, implantation should be delayeduntil infection is resolved

  • Inadequate or malformed bone that precludes adequate support or fixation of theprosthesis

  • Neuromuscular disorders that do not allow control of the joint

  • Significant injury to the brachial plexus

  • Non-functional deltoid muscles

  • The patient is unwilling or unable to comply with the post-operative careinstructions

  • Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4that affect follow-up care or treatment outcomes.

  • Alcohol, drug, or other subtance abuse

  • Any disease state that could adversaly affect the function or longevity of theimplant

  • Patient is pregnant

  • Patient is a prisoner

  • Patient who are currently involved in any personal injury litigation, medical-legalor worker's compensation claims

Study Design

Total Participants: 260
Study Start date:
September 23, 2020
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Dijklander Ziekenhuis

    Hoorn, 1624 NP
    Netherlands

    Active - Recruiting

  • Hospital for Special Surgery (HSS)

    New York, New York 10021
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.