Comparing two methods for shoulder joint replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of Exactech Guided Personalized Surgery (GPS) against conventional instrumentation techniques in optimizing the position of Reverse Shoulder Arthroplasty implants. It will evaluate the impact of implant positioning on range of motion (ROM) and patient-reported outcomes over a long-term follow-up period of up to 10 years, with a minimum follow-up of 2 years. The study will include patients who are indicated for reverse shoulder arthroplasty and will require compliance with pre- and postoperative visit requirements.

Why it matters

Who can join: the full rules

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 visit requirements
* 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 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 a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* 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 care instructions
* 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 DSM4 that 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 the implant
* Patient is pregnant
* Patient is a prisoner
* Patient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims

Where it's running

• Groene Hart Hospital
  Gouda, Hh, Netherlands Recruiting
• Dijklander Ziekenhuis
  Hoorn, Netherlands Recruiting

Study contacts

• Principal investigator: Robert J Hillen, MD — Dijklander Ziekenhuis
• Study coordinator: Rachael Craig
• Email: rachael.craig@advita.com
• Phone: 1-833-423-8482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.