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A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.
The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its instrumentation by analysis of fracture healing, functional outcome and adverse events.
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified.
The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clavicle open reduction and internal fixation | Device | Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with fracture healing | Number of subjects with fracture healing will be assessed through 12 months follow-up. Radiologic fracture healing is defined as: Bridging callus or no visible fracture lines on AP and 15-45° cephalic oblique radiographs. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Incidence of Adverse Events (Safety) | Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies. | 12 months |
| Range of Motion - Total shoulder motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| University of Michigan - Michigan Medicine |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Range of Motion (affected and contralateral), Forward elevation (maximum arm-trunk angle), External rotation (arm comfortably at side), External rotation (arm at 90 degrees of abduction), Internal rotation (thumb to back) spinous process, Cross-body adduction (antecubital fossa to opposite acromion (cm) |
| 12 months |
| Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up | The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score. | 12 months |
| Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L) | The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. | 12 months |
| Ann Arbor |
| Michigan |
| 48137 |
| United States |
| Slocum Research & Education Foundation | Eugene | Oregon | 97401 | United States |
| University of Texas San Antonio | San Antonio | Texas | 78229 | United States |
| General Foundation of the University of Valladolid | Valladolid | 47002 | Spain |