PHS: Perform Humeral System Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tornier Perform Humeral System - Stem Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem. |
Device: Tornier Perform Humeral - Stem
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline to last follow-up visit in ASES scores [Baseline through Follow-Up visits through 24 months Post-Op]
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
Secondary Outcome Measures
- Change from Baseline to last follow-up visit in Constant Murley scores [Baseline through Follow-Up visits through 10 years Post-Op]
Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder
- Change from Baseline to last follow-up visit in SANE scores [Baseline through Follow-Up visits through 10 years Post-Op]
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
- Change from Baseline to last follow-up visit in Subject Satisfaction scores [Baseline through Follow-Up visits through 10 years Post-Op]
Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
- Change from Baseline to last follow-up visit in EQ-5D scores [Baseline through Follow-Up visits through 10 years Post-Op]
The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.
- Number of device associated and procedure associated adverse events. [Baseline through Follow-Up visits through 10 years Post-Op]
- Rates of revision surgeries. [Baseline through Follow-Up visits through 10 years Post-Op]
- Evaluation of radiological imaging of the affected shoulder [Baseline through Follow-Up visits through 10 years Post-Op]
Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older at the time of the informed consent or non-opposition (when applicable).
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Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
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Willing and able to comply with the requirements of the study protocol.
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Considered a candidate for shoulder arthroplasty using a study device.
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Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Exclusion Criteria:
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Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
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Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
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Active local or systemic infection, sepsis, or osteomyelitis
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Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
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Significant injury to the brachial plexus
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Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
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Neuromuscular disease (e.g., joint neuropathy)
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Patient with known allergy to one of the product materials
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Metabolic disorders which may impair bone formation
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Patient pregnancy
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Planned for two-stage surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 2 | Orthopedic Institute | Sioux Falls | South Dakota | United States | 57105 |
Sponsors and Collaborators
- Stryker Trauma GmbH
Investigators
- Study Director: Rebecca Gibson, Stryker Trauma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20D-W-PHS-RM