ArthroplastyNCT04089371

A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

An observational study of Arthroplasty and Hemiarthroplasty, run by Stryker Trauma and Extremities at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Arthroplasty, Hemiarthroplasty, Shoulder Pain
What is being tested?: ReUnion Total Shoulder Arthroplasty (TSA) and ReUnion Reverse Shoulder Arthroplasty (RSA)
Type of treatment: Medical device
How many people: 10 participants
Where: 3 sitesUnited States
Study dates: 1 Oct 2019to 8 Jul 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects participating in this clinical investigation will be recruited from the investigator's standard patient population, where patients will be evaluated for clinical investigation participation based on the eligibility criteria.

Who may be able to join

Subject is willing to sign the informed consent.
Subject is willing and able to comply with postoperative scheduled clinical evaluations.
Subject is male or non-pregnant female and 18 years or older at the time of surgery.
When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
Aseptic necrosis of humeral head;
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;

Show all 13Show fewer

Proximal humeral fracture and/or dislocation;
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
Previous unsuccessful total shoulder replacement, resurfacing or other procedure
When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following:
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
Proximal humeral fracture
Previously failed shoulder joint replacement

Who cannot join

Subject has an active or suspected latent infection in or about the shoulder joint.
Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
Subject has severe concomitant disease(s)which may significantly affect the clinical outcome.
For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Steadman Hawkins
Greenville, South Carolina, 29615
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Great Plains Orthopaedics
Peoria, Illinois, 61605

Other trials in United States

About this study

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

Read the detailed description

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.

Conditions: Arthroplasty, Hemiarthroplasty, Shoulder Pain
Being tested: ReUnion Total Shoulder Arthroplasty (TSA), ReUnion Reverse Shoulder Arthroplasty (RSA)
Keywords: Arthroplasty, Hemiarthroplasty, Shoulder, Replacement
Medical subject headings: Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReUnion Total Shoulder Arthroplasty (TSA)Device
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
ReUnion Reverse Shoulder Arthroplasty (RSA)Device
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.

Study groups in NCT04089371
Study group	Role	What they receive
Arm A Total Shoulder Arthroplasty / Hemiarthroplasty		Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement. Receives: Device: ReUnion Total Shoulder Arthroplasty (TSA)
Arm B Reverse Shoulder Arthroplasty		Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement Receives: Device: ReUnion Reverse Shoulder Arthroplasty (RSA)

What is being measured

The primary outcome is the main question the study is designed to answer.

24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 24 months
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: *12 months (reporting 12mth as more data available)

Secondary outcomes (2)

Device-related Adverse Events
Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed.
Measured: 24 mths
Implant Survivorship
Time to mortality or last available assessment will be measured and reported.
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20198 Jul 2022

First posted13 Sep 2019
Study start1 Oct 2019
Primary completion8 Jul 2022
Study completion8 Jul 2022

Why it stopped: Sponsor Terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArthroplastyStudies of the same condition, open and under way.
More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04089371
Sponsor's protocol ID: ReUnion RFX Study
Status last verified: Jan 2025
First submitted: 11 Jul 2019
Last updated: 20 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
ClinicalTrials.gov ID: NCT04089371
Acronym / sponsor ID: ReUnion RFX Study
Conditions: Arthroplasty, Hemiarthroplasty, Shoulder Pain
Keywords: Arthroplasty, Hemiarthroplasty, Shoulder, Replacement
Study type: Observational
Recruitment status: TerminatedReason stopped: Sponsor Terminated
Enrolment: 10 participants (actual)
Lead sponsor: Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
Study start: 1 Oct 2019 (actual)
Primary completion: 8 Jul 2022 (actual)
Study completion: 8 Jul 2022 (actual)
First posted: 13 Sep 2019 (actual)
Results: Posted 20 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Arm A Total Shoulder Arthroplasty / Hemiarthroplasty	–	Device: ReUnion Total Shoulder Arthroplasty (TSA)Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement.
Arm B Reverse Shoulder Arthroplasty	–	Device: ReUnion Reverse Shoulder Arthroplasty (RSA)Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects participating in this clinical investigation will be recruited from the investigator's standard patient population, where patients will be evaluated for clinical investigation participation based on the eligibility criteria.

Key inclusion criteria (13 listed)

Subject is willing to sign the informed consent.
Subject is willing and able to comply with postoperative scheduled clinical evaluations.
Subject is male or non-pregnant female and 18 years or older at the time of surgery.
When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following:

Key exclusion criteria (7 listed)

Subject has an active or suspected latent infection in or about the shoulder joint.
Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.

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
ReUnion Total Shoulder Arthroplasty (TSA)The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Device	Arm A Total Shoulder Arthroplasty / Hemiarthroplasty
ReUnion Reverse Shoulder Arthroplasty (RSA)The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Device	Arm B Reverse Shoulder Arthroplasty

Primary outcome

24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
Time frame: 24 months
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
Time frame: *12 months (reporting 12mth as more data available)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

2 secondary outcomes

Device-related Adverse Events
Time frame: 24 mths
Implant Survivorship
Time frame: 10 years

Results and safety

Results posted to the registry on 20 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A Total Shoulder Arthroplasty / Hemiarthroplasty	0	0
Arm B Reverse Shoulder Arthroplasty	10	0

Primary outcome: 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm B Reverse Shoulder Arthroplasty n = 2
Value	86.50 (4.95)

Population analysed: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 24mths, only 2 out of 10 subjects with available data for Arm B.

Primary outcome: 12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)

Time frame: *12 months (reporting 12mth as more data available). Mean (Standard Deviation). Unit: score on a scale

Measure	Arm B Reverse Shoulder Arthroplasty n = 4
Value	65.25 (20.82)

Population analysed: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 12mths, only 4 out of 10 subjects with available data for Arm B.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected from Baseline until study was terminated early (~24 Months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A Total Shoulder Arthroplasty / Hemiarthroplasty	0 of 0	0 of 0	0
Arm B Reverse Shoulder Arthroplasty	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

Rebecca Gibson study director

Stryker Trauma

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty and Hemiarthroplasty, run by Stryker Trauma and Extremities at 3 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty) (time frame: 24 months). 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?

On the ClinicalTrials.gov record for NCT04089371.

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 20 Jan 2025.