Arthroplasty, Hemiarthroplasty, Shoulder Pain
Conditions
Keywords
Arthroplasty, Hemiarthroplasty, Shoulder, Replacement
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.
Interventions
DEVICEReUnion Total Shoulder Arthroplasty (TSA)
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
DEVICEReUnion Reverse Shoulder Arthroplasty (RSA)
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty) | 24 months | This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
| 12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty) | *12 months (reporting 12mth as more data available) | This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-related Adverse Events | 24 mths | Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed. |
| Implant Survivorship | 10 years | Time to mortality or last available assessment will be measured and reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A Total Shoulder Arthroplasty / Hemiarthroplasty Total Shoulder Arthroplasty (TSA) Humeral & Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement.
ReUnion Total Shoulder Arthroplasty (TSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only. | 0 |
| Arm B Reverse Shoulder Arthroplasty Reverse Shoulder Arthroplasty (RSA) Humeral & Glenoid Components as a primary, fracture or revision total shoulder replacement
ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated early | 0 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm B Reverse Shoulder Arthroplasty | Total |
|---|---|---|
| Age, Continuous | 70.80 years STANDARD_DEVIATION 7.64 | 70.80 years STANDARD_DEVIATION 7.64 |
| Body Mass Index (BMI) | 30.62 kg/m² STANDARD_DEVIATION 6.67 | 30.62 kg/m² STANDARD_DEVIATION 6.67 |
| Race/Ethnicity, Customized Ethnicity Caucasian | 10 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity N/A | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 10 |
| other Total, other adverse events | 0 / 0 | 0 / 10 |
| serious Total, serious adverse events | 0 / 0 | 0 / 10 |
Outcome results
Primary
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: *12 months (reporting 12mth as more data available)
Population: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 12mths, only 4 out of 10 subjects with available data for Arm B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm B Reverse Shoulder Arthroplasty | 12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty) | 65.25 score on a scale | Standard Deviation 20.82 |
Primary
24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: 24 months
Population: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 24mths, only 2 out of 10 subjects with available data for Arm B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm B Reverse Shoulder Arthroplasty | 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty) | 86.50 score on a scale | Standard Deviation 4.95 |
Secondary
Device-related Adverse Events
Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed.
Time frame: 24 mths
Population: No adverse events were reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm B Reverse Shoulder Arthroplasty | Device-related Adverse Events | 0 Participants |
Secondary
Implant Survivorship
Time to mortality or last available assessment will be measured and reported.
Time frame: 10 years
Population: Due to early study termination, the planned implant survivorship analysis could not be performed; therefore, secondary efficacy/performance could not be assessed. It is to be noted that during the study, no intraoperative nor postoperative AEs were reported, as well as no reported subject deaths, therefore the raw survival for the 10 subjects in Arm B at the time of study closure was 100%.