Shoulder Arthroplasty
Conditions
Brief summary
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) 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 RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA 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.
Interventions
DEVICEReUnion RSA System
The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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'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 * Failed previous 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 concomitant disease(s) which may significantly affect the clinical outcome. * Subject has traumatic or pathologic fracture of the proximal humerus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events. | 24 months | Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events. |
| Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events. | 24 months | Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events. |
| Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System. | 24 months | Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReUnion RSA System 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
* Failed previous shoulder joint replacement
ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Missing- Study Site Closed | 27 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | ReUnion RSA System |
|---|---|
| Age, Continuous | 69.80 years STANDARD_DEVIATION 8.32 |
| Body Mass Index (BMI) | 29.49 kg/m² STANDARD_DEVIATION 5.13 |
| Race/Ethnicity, Customized Ethnicity Black or African | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 92 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 4 Participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 102 |
| other Total, other adverse events | 20 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
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: 54 out of 102 Subjects had available data at 24mths.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReUnion RSA System | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 88.19 units on a scale | Standard Deviation 15.39 |
Secondary
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.
Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReUnion RSA System | Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System. | 101 Participants |
Secondary
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.
Time frame: 24 months
Population: 4 out of 102 Subjects with reportable Intra-operative Adverse Events. Please see Adverse Events section for break-down.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReUnion RSA System | Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events. | 4 Participants |
Secondary
Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events.
Time frame: 24 months
Population: 16 out of 102 Subjects with reportable post-operative Adverse Events. Please see Adverse Events section for break-down.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReUnion RSA System | Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events. | 16 Participants |