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This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORMâ„¢ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORMâ„¢ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tornier Perform Humeral System - Stem | Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tornier Perform Humeral - Stem | Device | The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to last follow-up visit in ASES scores | 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 | Baseline through Follow-Up visits through 24 months Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to last follow-up visit in Constant Murley scores | 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 | Baseline through Follow-Up visits through 10 years Post-Op |
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Inclusion Criteria:
Exclusion Criteria:
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Patients intended for the total or partial replacement of the glenohumeral articulation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meredith Schreier | Contact | 901-232-2704 | meredith.schreier@stryker.com | |
| Amjad Uneisi | Contact | amjad.uneisi@stryker.com |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Healthcare | Recruiting | Lexington | Kentucky | 40503 | United States |
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| Change from Baseline to last follow-up visit in SANE scores | SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100% | Baseline through Follow-Up visits through 10 years Post-Op |
| Change from Baseline to last follow-up visit in Subject Satisfaction scores | Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction | Baseline through Follow-Up visits through 10 years Post-Op |
| Change from Baseline to last follow-up visit in EQ-5D scores | 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. | Baseline through Follow-Up visits through 10 years Post-Op |
| 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 | Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only). | Baseline through Follow-Up visits through 10 years Post-Op |
| Summit Orthopedics | Recruiting | Eagan | Minnesota | 55121 | United States |
|
| Mayo Clinic | Terminated | Rochester | Minnesota | 55905 | United States |
| Washington University | Active, not recruiting | St Louis | Missouri | 63110 | United States |
| Orthopedic Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| Roth McFarlane Hand and Upper Limb Centre | Active, not recruiting | London | Ontario | N6A 4L6 | Canada |
| Orthopedic Center Santy | Active, not recruiting | Lyon | 69008 | France |
| Schulthess Klinik | Active, not recruiting | Zurich | CH-8008 | Switzerland |
| Wrightington Hospital | Active, not recruiting | Wigan | Lancashire | WN6 9EP | United Kingdom |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D000070657 | Crystal Arthropathies |
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