TechnologyNCT05615259
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
An observational study of Technology and Comparison, run by Exactech at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Technology, Comparison
- How many people
- 260 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Sep 2020to 30 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Groene Hart Hospital
Gouda, HH, 2803
- Recruiting
Dijklander Ziekenhuis
Hoorn, 1624 NP
About this study
Official title: 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.
- Conditions
- Technology, Comparison
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
Measured: Through study completion, an average of 1 per year
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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start23 Sep 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J Hillen, MD, Principal investigator, Dijklander ZiekenhuisRon Onstenk, MD, Principal investigator, Groene Hart Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615259
- Sponsor's protocol ID
- CR18-004
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation
- ClinicalTrials.gov ID
- NCT05615259
- Acronym / sponsor ID
- CR18-004
- Conditions
- Technology, Comparison
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SST-12
Time frame: Through study completion, an average of 1 per year
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%
SPADI
Time frame: Through study completion, an average of 1 per year
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
Constant
Time frame: Through study completion, an average of 1 per year
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
ASES
Time frame: Through study completion, an average of 1 per year
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
UCLA
Time frame: Through study completion, an average of 1 per year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Hillen, MD principal investigator
Dijklander Ziekenhuis
Ron Onstenk, MD principal investigator
Groene Hart Ziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Technology and Comparison, run by Exactech at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachael Craig (1-833-423-8482, rachael.craig@advita.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SST-12 (time frame: Through study completion, an average of 1 per year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.