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Sponsor Terminated
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReUnion TSA System | Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReUnion TSA System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 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 and Post-operative Adverse Events Will be Measured. | Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events. | 24 mths |
| 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. |
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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 has one or more of the following:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Plains Orthopedics | Peoria | Illinois | 61605 | United States | ||
| Tennessee Orthopaedic Alliance |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReUnion TSA System | Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReUnion TSA System | Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
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. |
| 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 | 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. | The Total ASES Shoulder Score (1 & 2 year LOCF) was available for 24 subjects | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
From Baseline until study was terminated early (~27 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 TSA System | Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant breakage/wear, humeral or glenoidal | Product Issues | Systematic Assessment |
As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.
| 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 efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System. |
| From Baseline to last recorded follow-up (~27 Months) |
| Nashville |
| Michigan |
| 37209 |
| United States |
| Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina | 29615 | United States |
| Sponsor Closure |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 and Post-operative Adverse Events Will be Measured. | Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events. | 5 out of 51 Subjects with reportable Adverse Events. Please see Adverse Events section for break-down. | Posted | Count of Participants | Participants | 24 mths |
|
|
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| Secondary | 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. | Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System. | 2 out of 51 Subjects had this data available. | Posted | Mean | Standard Deviation | days | From Baseline to last recorded follow-up (~27 Months) |
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| 0 |
| 51 |
| 0 |
| 51 |
| 5 |
| 51 |
| Nerve injury, mild (minor motor or sensory loss, or spontaneous recovery) | Nervous system disorders | Systematic Assessment |
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| Nerve injury, severe (significant motor or sensory loss or requiring surgical revision) | Nervous system disorders | Systematic Assessment |
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| Rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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