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

NCT04089371 | Terminated Results FDA Device

• 1 other identifier: ReUnion RFX Study
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Arthroplasty; Hemiarthroplasty; Shoulder Pain

Keywords

Arthroplasty; Hemiarthroplasty; Shoulder; Replacement

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  *12 months (reporting 12mth as more data available)

Secondary Outcomes (2)

• Device-related Adverse Events

  24 mths

• Implant Survivorship

  10 years

Study Arms (2)

Arm A Total Shoulder Arthroplasty / Hemiarthroplasty

Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement.

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

Device: ReUnion Reverse Shoulder Arthroplasty (RSA)

Interventions

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.

Arm A Total Shoulder Arthroplasty / Hemiarthroplasty

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.

Arm B Reverse Shoulder Arthroplasty

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (3)

Great Plains Orthopaedics

Peoria, Illinois, 61605, United States

Location

Steadman Hawkins

Greenville, South Carolina, 29615, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.

Results Point of Contact

• Title: Monica Fleeman
• Organization: Stryker

monica.fleeman@stryker.com

251-465-5969

Study Officials

• Rebecca Gibson

  Stryker Trauma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: September 13, 2019
• Study Start: October 1, 2019
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)