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Sponsor decision to stop at 2 year follow-up
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReUnion RSA System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events. |
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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:
Exclusion Criteria:
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80 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.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Plains Orthopedics | Peoria | Illinois | 61605 | United States | ||
| Steadman Hawkins Clinic of the Carolinas |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 54 out of 102 Subjects had available data at 24mths. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
24 months
Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep infection | Infections and infestations | Systematic Assessment |
The protocol allowed for subjects to be assessed annually up to 10 years after the index procedure, but the study was closed early and collected assessments only through 24 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Fleeman | Stryker | 251-465-5969 | monica.fleeman@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Aug 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2021 | Aug 8, 2024 | SAP_001.pdf |
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Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events. |
| 24 months |
| 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. | 24 months |
| Greenville |
| South Carolina |
| 29615 |
| United States |
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37209 | United States |
| Withdrawal by Subject |
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| Missing- Study Site Closed |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
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|
|
| 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. | 4 out of 102 Subjects with reportable Intra-operative Adverse Events. Please see Adverse Events section for break-down. | Posted | Count of Participants | Participants | 24 months |
|
|
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| 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. | 16 out of 102 Subjects with reportable post-operative Adverse Events. Please see Adverse Events section for break-down. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24 months |
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|
|
| 1 |
| 102 |
| 0 |
| 102 |
| 20 |
| 102 |
| Heterotopic ossification, asymptomatic | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heterotopic ossification, symptomatic | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Intraoperative fracture of the glenoid | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Intraoperative fracture of the humerus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Late infection (e.g. hematogenous or protracted) | Infections and infestations | Systematic Assessment |
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| Pain related to the implant, severe | Product Issues | Systematic Assessment |
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| Radiographic lucency, humeral | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stress fracture of the acromion or the scapular neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Wound complications (e.g. hematoma, wound healing disturbances) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other (inferior osteophyte off of glenoid) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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