Osteoarthritis ShoulderNCT06078865
FX Shoulder Prospective Clinical Study
An observational study of Osteoarthritis Shoulder and Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by FX Shoulder Solutions at 4 sites in United States.
Trial summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- What is being tested?
- FX Artificial Shoulder Prosthesis
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Mar 2021to 30 Dec 2031
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
Who may be able to join
- Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Who cannot join
- Patient who does not meet the inclusion criteria.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Texas Orthopedic Specialists
Bedford, Texas, 76021
Amber Morgan, 817.510.4022, amber@txortho.net
Howard Harris, MD
- Recruiting
OrthoArizona
Gilbert, Arizona, 85297
William Paterson, MD, 480 284-4658, wpaterson@orthoarizona.org
lquarles@orthoarizona.org
- Recruiting
First Settlement Orthopedics
Marietta, Ohio, 45750
Angie Miller, FNP-BC, 740 373-8456, angie_d_miller@yahoo.com
Joette Fetty, CPC, 740 373-8756 ext. 142, joefetty@mhsystem.org
- Recruiting
Orthopedics Rhode Island
Wakefield, Rhode Island, 02879
Jennifer Stedman, 401 777-7000 ext. 2322, jstedman@orthopedicsri.com]
Michael Bradley, MD
About this study
Official title: FX Shoulder Post-Market Follow-Up Clinical Study
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Read the detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.
To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
- Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline
- No continuous radiolucency or device migration/subsidence
- No revision surgery
- No serious device related adverse event
The Registry will continue to follow patients to 10 years post-operative to track survivorship.
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- Being tested
- FX Artificial Shoulder Prosthesis
- Keywords
- Osteoarthritis, Fracture, rotator cuff tear, shoulder trauma
- Medical subject headings
- Shoulder Fractures, Osteoarthritis, Fractures, Bone, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX Artificial Shoulder ProsthesisDevice
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions Receives: Device: FX Artificial Shoulder Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline.
No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event.
Measured: 2 years
Survivorship
Follow patient's post-operative to track survivorship.
Measured: 10 years
Secondary outcomes (10)
Adjusted Constant Score
The Constant-Murley score (CMS) is a validated 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points) with the subject completing the assessment prior to the Investigator completing their part of the assessment. The higher the score, the higher the quality of the function.
An Adjusted Constant score will be calculated using normalized values to account for age and gender, as based upon anatomical gender at birth.
Measured: 6 weeks, 3, 6, 12, and 24 months.
QuickDASH
QuickDASH measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.
The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. The higher the score, the higher the function and lower pain in the patient.
Measured: 6 weeks, 3, 6, 12, and 24 months.
American Shoulder and Elbow Surgeon (ASES)
ASES is a validated patient-reported outcome which is composed of 10 functional questions and one pain VAS. The total score is of 100 maximum points and weighted evenly between pain and function
Measured: 6 weeks, 3, 6, 12, and 24 months
Visual Analog Scale (VAS).
A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length.
Measured: 6 weeks, 3, 6, 12, and 24 months
Range of Motion (ROM)
The patient performs active movements in all functional planes for the shoulder. Includes flexion, extension, abduction, adduction and internal and external rotation. Investigator estimates the range of movement and compares the affected with the unaffected shoulder and the normal expected range.
Measured: 6 weeks, 3, 6, 12, and 24 months
Secondary Surgical Interventions (SSI)
SSI's are re-operations, revisions, and removals.
Measured: 24 months and at 5 years postoperative
Serious Adverse Event
- Led to a death.
- Resulted in life threatening illness or injury.
- Resulted in patient hospitalization or prolongation of existing hospitalization.
- Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage.
- Led to a congenital abnormality or birth defect.
Measured: 24 months and at 5 years postoperative
Serious Adverse Device Effects (SADE)
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
Measured: 24 months and at 5 years postoperative.
Radiographic Reviews and Assessments.
Monitor implant integrity and signs of implant loosening.
Measured: 24 months and at 5 years postoperative.
Survival
Subject disposition.
Measured: 24 months and at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start31 Mar 2021
- Primary completion30 Dec 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- FX Shoulder Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Trier, PhD, Study director, FX Shoulder Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078865
- Sponsor's protocol ID
- FXShoulder2020-01
- Other IDs
- FXShoulder2020-1
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FX Shoulder Post-Market Follow-Up Clinical Study
- ClinicalTrials.gov ID
- NCT06078865
- Acronym / sponsor ID
- FXShoulder2020-01
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- Keywords
- Osteoarthritis, Fracture, rotator cuff tear, shoulder trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- FX Shoulder SolutionsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 12 Oct 2023 (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.
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.
To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
- Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline
- No continuous radiolucency or device migration/subsidence
- No revision surgery
- No serious device related adverse event
The Registry will continue to follow patients to 10 years post-operative to track survivorship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Device: FX Artificial Shoulder ProsthesisSubjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
Key inclusion criteria (1 listed)
- Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Key exclusion criteria (1 listed)
- Patient who does not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX Artificial Shoulder ProsthesisHumelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System | Device | Subjects |
Primary outcome
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
Time frame: 2 years
Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline. No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event.
Survivorship
Time frame: 10 years
Follow patient's post-operative to track survivorship.
10 secondary outcomes
Adjusted Constant Score
Time frame: 6 weeks, 3, 6, 12, and 24 months.
QuickDASH
Time frame: 6 weeks, 3, 6, 12, and 24 months.
American Shoulder and Elbow Surgeon (ASES)
Time frame: 6 weeks, 3, 6, 12, and 24 months
Visual Analog Scale (VAS).
Time frame: 6 weeks, 3, 6, 12, and 24 months
Range of Motion (ROM)
Time frame: 6 weeks, 3, 6, 12, and 24 months
Secondary Surgical Interventions (SSI)
Time frame: 24 months and at 5 years postoperative
Serious Adverse Event
Time frame: 24 months and at 5 years postoperative
Serious Adverse Device Effects (SADE)
Time frame: 24 months and at 5 years postoperative.
Radiographic Reviews and Assessments.
Time frame: 24 months and at 5 years postoperative.
Survival
Time frame: 24 months and at 5 years
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 9 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Kathy Trier, PhD study director
FX Shoulder Solutions
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Shoulder and Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by FX Shoulder Solutions at 4 sites in United States.
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 1 inclusion and 1 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 Brian Wasonga, MHA (800-280-0775, bwasonga@fxshouldersolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): (time frame: 2 years). The study lists 2 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 9 Feb 2026.