A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

NCT03880955 | Terminated Results FDA Device

• 1 other identifier: ReUnion RSA Study
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

Brief Summary

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

Conditions

Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  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

Secondary Outcomes (3)

• Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.

  24 months

• Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.

  24 months

• Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.

  24 months

Study Arms (1)

ReUnion RSA System

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 * Failed previous shoulder joint replacement

Device: ReUnion RSA System

Interventions

ReUnion RSA System DEVICE

The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.

ReUnion RSA System

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

80 subjects are to be enrolled in this clinical investigation. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

You may qualify if:

• Subject is willing to sign the informed consent.
• Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
• Subject is male or non-pregnant female and 18 years or older at the time of surgery.
• 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
• Failed previous 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 concomitant disease(s) which may significantly affect the clinical outcome.
• Subject has traumatic or pathologic fracture of the proximal humerus

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (3)

Great Plains Orthopedics

Peoria, Illinois, 61605, United States

Location

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

Location

Limitations and Caveats

The protocol allowed for subjects to be assessed annually up to 10 years after the index procedure, but the study was closed early and collected assessments only through 24 months.

Results Point of Contact

• Title: Monica Fleeman
• Organization: Stryker

monica.fleeman@stryker.com

251-465-5969

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  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: March 7, 2019
• First Posted: March 19, 2019
• Study Start: June 25, 2019
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)