Comparing two methods for shoulder joint replacement surgery

A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation

This study is testing whether a new guided surgery method for shoulder joint replacement can improve movement and satisfaction compared to traditional techniques for patients needing this surgery.

Quick facts

• Study type: Observational
• Enrollment: 260 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Exactech (industry)
• Locations: 1 site (Hoorn)
• Trial ID: NCT05615259 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 21 and older who are indicated for reverse shoulder arthroplasty and can commit to the study's follow-up requirements.

Not a fit: Patients undergoing revision shoulder arthroplasty or those with specific contraindications such as infections or inadequate bone support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction in shoulder arthroplasty procedures.

How similar studies have performed: While this study employs a novel approach with GPS technology, similar studies comparing surgical techniques have shown promising results in optimizing surgical outcomes.

Eligibility criteria

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 this trial is running

Hoorn

• Dijklander Ziekenhuis — Hoorn, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Robert J Hillen, MD — Dijklander Ziekenhuis
• Study coordinator: Rachael Craig

Conditions: Technology, Comparison