- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858517
A Post-Market Clinical Evaluation of the ReUnion TSA System
July 21, 2022 updated by: Stryker Trauma GmbH
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Peoria, Illinois, United States, 61605
- Great Plains Orthopedics
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-
Michigan
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Nashville, Michigan, United States, 37209
- Tennessee Orthopaedic Alliance
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South Carolina
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Greenville, South Carolina, United States, 29615
- Steadman Hawkins Clinic of the Carolinas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ReUnion TSA System
Subject with one or more of the following diagnoses will be treated with the 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 years
|
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.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2019
Primary Completion (Actual)
July 8, 2022
Study Completion (Actual)
July 8, 2022
Study Registration Dates
First Submitted
February 27, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
February 28, 2019
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 21, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ReUnion TSA Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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