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A Post-Market Clinical Evaluation of the ReUnion TSA System

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ClinicalTrials.gov Identifier: NCT03858517
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

Study Description
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Brief Summary:
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) 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 TSA System

Detailed Description:
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Market Clinical Evaluation of the ReUnion TSA System
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2030
Groups and Cohorts
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Group/Cohort Intervention/treatment
ReUnion TSA System

Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:

  • Aseptic necrosis of the humeral head
  • Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
  • Failed previous total shoulder replacement, resurfacing or other procedure
 Device: ReUnion TSA System
The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA 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.


Outcome Measures
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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 adverse events.

  2. Efficacy will be measured by monitoring all implant survivorship in all subjects who have the total or partial prosthesis with full or partial implant survival. [ Time Frame: 10 years ]
    Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 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 has one or more of the following:

    • Aseptic necrosis of the humeral head
    • Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
    • Failed previous total shoulder replacement, resurfacing or other procedure

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 absent, irreparable or non-functioning rotator cuff and other essential muscles.
  • Subject has concomitant disease(s) which may significantly affect the clinical outcome.
  • Subject has traumatic or pathologic fracture of the proximal humerus.
Contacts and Locations
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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): NCT03858517


Contacts
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Contact: Colleen Bordeaux 910-515-0490 colleen.bordeaux@stryker.com

Locations
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United States, Illinois
Great Plains Orthopedics Recruiting
Peoria, Illinois, United States, 61605
Contact: Eleni Stroumpi, MD    309-655-6988    estrou2@uic.edu   
Principal Investigator: Miguel Ramirez         
United States, Michigan
Tennessee Orthopaedic Alliance Recruiting
Nashville, Michigan, United States, 37209
Contact: Rena Clayton Rolfe    615-719-2922    renacrolfe@gmail.com   
Principal Investigator: Matthew Willis         
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas Recruiting
Greenville, South Carolina, United States, 29615
Contact: Kyle Adams    864-454-7458    kyle.adams@hawkinsfoundation.com   
Principal Investigator: Stefan Tolan         
Principal Investigator: Stephan Pill         
Sponsors and Collaborators
Stryker Trauma GmbH
Investigators
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Study Director: Rebecca Gibson Stryker Trauma
More Information
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Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT03858517    
Other Study ID Numbers: ReUnion TSA Study
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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
Product Manufactured in and Exported from the U.S.: Yes