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

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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty; Hemiarthroplasty; Shoulder Pain
• Intervention / Treatment: Device: ReUnion Total Shoulder Arthroplasty (TSA); Device: ReUnion Reverse Shoulder Arthroplasty (RSA)

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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; Reverse Shoulder Arthroplasty (RSA) Humeral & Glenoid Components as a primary, fracture or revision total shoulder replacement	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-month mean ASES shoulder score: Arm A (Total Shoulder Arthoplasty/Hemiarthroplasty)	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.	24 months
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years
Implant survivorship	Time to mortality or last available assessment will be measured and reported.	10 years

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Arthroplasty; Hemiarthroplasty; Shoulder; Replacement
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: ReUnion RFX Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No