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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Technology; Comparison

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Sandrine Angibaud; Phone Number: 352-377-1140; Email: sandrine.angibaud@exac.com
• Study Contact Backup: Name: Rachael Craig; Phone Number: 352-377-1140; Email: rachael.craig@exac.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery (HSS)
      • Contact: Phone Number: 845-608-2592
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Kaitlyn Shank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant	Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain	Through study completion, an average of 1 per year
ASES	American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition	Through study completion, an average of 1 per year
SST-12	Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%	Through study completion, an average of 1 per year
SPADI	Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities	Through study completion, an average of 1 per year
UCLA	University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes	Through study completion, an average of 1 per year

Collaborators and Investigators

• Sponsor: Exactech
• Investigators: Principal Investigator: Lawrence Gulotta, MD, Hospital for Special Surgery, New York; Principal Investigator: Brian Werner, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR18-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No