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

Technology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615259
• Other study ID #: CR18-004
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: September 30, 2031

Study information

• Verified date: February 2024
• Source: Exactech
• Contact: Rachael Craig
• Phone: 352-377-1140
• Email: rachael.craig[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 30, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comparison
• Technology

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Hospital for Special Surgery (HSS)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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