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This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.
A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. | Experimental | Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A.L.P.S. Proximal Humerus Plating System | Device | Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-operation | Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire | Pain, function and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0 to 100. 100 is the highest score and indicates the greatest function while 0 is the lowest score. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research & Education | Tampa | Florida | 33637 | United States | ||
| Sydney Adventist Hospital |
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| Shoulder range of motion measurement |
Shoulder range of motion is assessed in degrees of directional movement. This will be measured during a physical exam by the investigator. Values measured include active and passive range of motion. |
| 2 years |
| Clinical performance of the device is assessed using x-ray capture | X-ray capture will be used to analyze fracture healing | 2 years |
| Wahroonga |
| New South Wales |
| 2076 |
| Australia |
| The Research Institute of McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Korea University Anam Hospital | Seoul | Seoul | 02841 | South Korea |
| Hallym University Kangnam Sacred Hearth Hospital | Seoul | Seoul | 07441 | South Korea |
| Inje University Seoul Paik Hospital | Seoul | Seoul | 07441 | South Korea |
| Bone and Motion Training and Research Foundation | Granges-Paccot | Granges-Paccot | 1763 | Switzerland |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D012784 | Shoulder Fractures |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D050723 | Fractures, Bone |
| D000070599 | Shoulder Injuries |
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