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

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ClinicalTrials.gov Identifier: NCT03880955
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

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.

Condition or disease Intervention/treatment
Shoulder Arthroplasty Device: ReUnion RSA System

Detailed Description:
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Market Clinical Evaluation of theReUnion Reverse Shoulder Arthroplasty (RSA)System
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2030

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: 24 Months ]
    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


Secondary Outcome Measures :
  1. Safety will be measured by capturing the incidence rate of device-related intra-operative and post-operative adverse events will be measured. [ Time Frame: 10 years ]
    Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative and post-operative adverse events.

  2. Efficacy will be measured by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System. [ Time Frame: 10 years ]
    Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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

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 concomitant disease(s) which may significantly affect the clinical outcome.
  • Subject has traumatic or pathologic fracture of the proximal humerus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880955


Contacts
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Contact: Georgia Mitchell, MA 609-709-9373 georgia.mitchell@stryker.com

Locations
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United States, South Carolina
Steadman Hawkins Clinic of the Carolinas Not yet recruiting
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Stryker Trauma GmbH
Investigators
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Study Director: Georgia Mitchell, MA Stryker Trauma

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Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT03880955     History of Changes
Other Study ID Numbers: ReUnion RSA Study
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes