Rotator Cuff Syndrome of Shoulder and Allied DisordersNCT06077942
FX Shoulder Solutions Retrospective / Prospective Clinical Study
An observational study of Rotator Cuff Syndrome of Shoulder and Allied Disorders and Osteoarthritis Shoulder, run by FX Shoulder Solutions at 2 sites in United States.
Trial summary
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
- What is being tested?
- FX Artificial Shoulder Prosthesis
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2022to 30 Dec 2032
- 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: Patients who received the study devices implanted by the Investigator in accordance with the Indications for Use beginning January 1, 2018, through June 30, 2023.
Who may be able to join
- Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.
Who cannot join
- Patient who does not meet the inclusion criteria above
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
OrthoArizona
Gilbert, Arizona, 85297
Justin Meyers, 480-964-2908, jmyers@orthoarizona.org
Lauren Quarles, 480 284-4658, lquarles@orthoarizona.org
- Recruiting
Advanced Orthopedics Institute
The Villages, Florida, 32159
Kevin Trier, BS, 727-735-1484, KTC@goaoi.com
Ted McKittrick, 7242493364, tmckittrick@fxshouldersolutions.com
About this study
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Read the detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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.
Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.
Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
- Conditions
- Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
- Being tested
- FX Artificial Shoulder Prosthesis
- Keywords
- Osteoarthritis, Roartator Cuff, Fracture, Arthroplasty
- Medical subject headings
- Shoulder Fractures, Osteoarthritis, Fractures, Bone
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, PRCT II Fracture Plate, V-135
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed 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.
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
- Adjusted Constant Score > 70
- No continuous radiolucency or device migration/subsidence
- No revision surgery or removal
- No serious device related adverse event
The Study will continue to follow patients prospectively to 10 years postoperative 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: 3, 6, 12, 24 months, 5 and 10 years.
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: 3, 6, 12, 24 months, 5 and 10 years.
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: 3, 6, 12, 24 months, 5 and 10 years.
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.
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: 3, 6, 12, 24 months, 5 and 10 years
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: 3, 6, 12, 24 months, 5 and 10 years.
Number of Participants Who Have a Secondary Surgical Intervention (SSI)
SSI's are re-operations, revisions, and removals.
Measured: 24 months and at 5 and 10 years
Device Related Adverse Events.
An adverse event that is related to the use of a device.
Measured: 24 months and at 5 and 10 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 and 10 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 and 10 years postoperative.
Number of Participants with Radiographic Reviews and Assessments.
Monitor implant integrity and signs of implant loosening
Measured: 24 months, at 5 years and 10 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start6 Dec 2022
- Primary completion30 Dec 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Syndrome of Shoulder and Allied DisordersStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FX Shoulder Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Rogers, BS, Study director, FX Shoulder Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077942
- Sponsor's protocol ID
- FXShoulder2022-01
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FX Shoulder Solutions Retrospective / Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06077942
- Acronym / sponsor ID
- FXShoulder2022-01
- Conditions
- Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
- Keywords
- Osteoarthritis, Roartator Cuff, Fracture, Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- FX Shoulder SolutionsIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Dec 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 11 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.
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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.
Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.
Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- 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 and distributed by FX Shoulder Solutions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received the study devices implanted by the Investigator in accordance with the Indications for Use beginning January 1, 2018, through June 30, 2023.
Key inclusion criteria (1 listed)
- Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.
Key exclusion criteria (1 listed)
- Patient who does not meet the inclusion criteria above
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, PRCT II Fracture Plate, V-135 | Device | Subjects |
Primary outcome
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
Time frame: 10 years
* Adjusted Constant Score > 70 * No continuous radiolucency or device migration/subsidence * No revision surgery or removal * No serious device related adverse event The Study will continue to follow patients prospectively to 10 years postoperative to track survivorship.
10 secondary outcomes
Adjusted Constant Score
Time frame: 3, 6, 12, 24 months, 5 and 10 years.
QuickDASH
Time frame: 3, 6, 12, 24 months, 5 and 10 years.
American Shoulder and Elbow Surgeon (ASES)
Time frame: 3, 6, 12, 24 months, 5 and 10 years.
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.
Time frame: 3, 6, 12, 24 months, 5 and 10 years
Range of Motion
Time frame: 3, 6, 12, 24 months, 5 and 10 years.
Number of Participants Who Have a Secondary Surgical Intervention (SSI)
Time frame: 24 months and at 5 and 10 years
Device Related Adverse Events.
Time frame: 24 months and at 5 and 10 years postoperative
Serious Adverse Event
Time frame: 24 months and at 5 and 10 years postoperative
Serious Adverse Device Effects (SADE)
Time frame: 24 months and at 5 and 10 years postoperative.
Number of Participants with Radiographic Reviews and Assessments.
Time frame: 24 months, at 5 years and 10 years postoperative
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 12 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Syndrome of Shoulder and Allied Disorders
RecruitingObservational study
FX Shoulder Prospective Clinical Study
Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders
Not yet recruitingObservational study
Assessing Shoulder Pathways Involving the Cuff
Rotator Cuff Shoulder Syndrome and Allied Disorders, Rotator Cuff Related Shoulder Pain
Enrolling by invitation
Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions
Shoulder Disease, Shoulder Impingement
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.
Brian Rogers, BS study director
FX Shoulder Solutions
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 Rotator Cuff Syndrome of Shoulder and Allied Disorders and Osteoarthritis Shoulder, run by FX Shoulder Solutions at 2 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 12 Oct 2023. 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 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 Ted McKittrick, BA (7242493364, tmckittrick@fxshouldersolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments. (time frame: 10 years). 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 12 Oct 2023.