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This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations.
Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective.
The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations.
Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective.
The primary outcome measure will be measured by the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.
Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.
Device revision and adverse events (AEs) will be assessed annually throughout the study. Range of motion and radiographic imaging assessments will also be performed at Years 1, 2, 5 and 10 post-operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system | Commercially available shoulder system available in both anatomic and reversed configurations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system | Device | Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system is intended for use as:
The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Improvement from Baseline to last follow-up visit in ASES Score | ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function | 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Score | A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. | through study completion, an average of 1 year |
| SANE |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 110 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reversed total shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCA Healthcare Research Institute | Denver | Colorado | 80222 | United States | ||
| Coastal Orthopedics |
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|
Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. |
| through study completion, an average of 1 year |
| EQ 5-D | Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. | through study completion, an average of 1 year |
| Patient Satisfaction | Single subjective question "How satisfied are you with your shoulder?" | through study completion, an average of 1 year |
| Radiographic Findings | Images will be reviewed by a single orthopedic surgeon to assess for standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics. | Baseline, 1 year, 2 year, 5 year and 10 year |
| Bradenton |
| Florida |
| 34212 |
| United States |
| Foundation for Orthopaedic Research & Education | Tampa | Florida | 33637 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D006810 | Humeral Fractures |
| D010020 | Osteonecrosis |
| D000070636 | Rotator Cuff Injuries |
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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