Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorExactech
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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%
Time frame
Through study completion, an average of 1 per year2
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
Time frame
Through study completion, an average of 1 per year3
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
Time frame
Through study completion, an average of 1 per year4
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
Time frame
Through study completion, an average of 1 per year Source ClinicalTrials.gov