Clinical trial NCT04089371: A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
Official title: A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthroplasty
Hemiarthroplasty
Shoulder Pain
Keywords: Arthroplasty
Hemiarthroplasty
Shoulder
Replacement
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects participating in this clinical investigation will be recruited from the investigator's standard patient population, where patients will be evaluated for clinical investigation participation based on the eligibility criteria.

Brief summary: This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient 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 RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative 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.

Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign the informed consent.
* Subject is willing and able to comply with postoperative scheduled clinical evaluations.
* Subject is male or non-pregnant female and 18 years or older at the time of surgery.
* When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:

  * Aseptic necrosis of humeral head;
  * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
  * Proximal humeral fracture and/or dislocation;
  * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
  * Previous unsuccessful total shoulder replacement, resurfacing or other procedure
* When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, 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;
  * Proximal humeral fracture
  * Previously failed 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 severe concomitant disease(s)which may significantly affect the clinical outcome.
* For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles

Primary outcomes:
measure: 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
timeFrame: 24 months
measure: 12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
timeFrame: *12 months (reporting 12mth as more data available)
Secondary outcomes:
measure: Device-related Adverse Events
timeFrame: 24 mths
measure: Implant Survivorship
timeFrame: 10 years
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Great Plains Orthopaedics
state: Illinois
city: Greenville
country: United States
facility: Steadman Hawkins
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
Study officials:
affiliation: Stryker Trauma
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: