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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

Tracking Information
First Submitted Date February 27, 2019
First Posted Date February 28, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date June 25, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2019)
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.
Original Primary Outcome Measures
 (submitted: February 27, 2019)
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.
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: February 27, 2019)
  • Safety by measuring incidence of adverse events [ Time Frame: 10 years ]
    Incidence of device-related intra-operative and post-operative adverse events
  • Efficacy by measuring implant survivorship [ Time Frame: 10 years ]
    Implant survivorship will be monitored in all subjects who have the total or partial prosthesis with full or partial implant survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post-Market Clinical Evaluation of the ReUnion TSA System
Official Title A Post-Market Clinical Evaluation of the ReUnion TSA System
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Shoulder Arthroplasty
Intervention 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.
Study Groups/Cohorts 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
Intervention: Device: ReUnion TSA System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2030
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Colleen Bordeaux 910-515-0490 colleen.bordeaux@stryker.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03858517
Other Study ID Numbers ReUnion TSA Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stryker Trauma GmbH
Study Sponsor Stryker Trauma GmbH
Collaborators Not Provided
Investigators
Study Director: Rebecca Gibson Stryker Trauma
PRS Account Stryker Trauma GmbH
Verification Date October 2020