Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03489408|
Recruitment Status : Terminated (Study stopped due to business decision to not continue to gather clinical evidence on product)
First Posted : April 5, 2018
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment|
|Humeral Fractures, Proximal||Device: Conventus Cage™ PH|
The Conventus CAGE™ PH (PH Cage) System Post-Approval Prospective Study (Study) is a multi-center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.
Specifically, the study will provide:
- Device safety and patient outcome data.
- Device usage data.
- Performance data for the implant procedure.
- Early economic benefit data.
Patient Assessments Demographic and general health data will be collected on all patients at the baseline appointment to ensure subjects meet inclusion/exclusion criteria. In addition, to these data, x-rays and adverse event reports related to the implanted device, surgical procedure and/or study data collection methods will be collected.
Patients will be seen at baseline, 2-, 6- and 12-week, 1- and 2-year post op.
Patient participation in this study is voluntary. However, post-implant patient follow-up adds to the medical community's understanding of proximal humerus fracture patient outcomes, as well as the safety and performance of the PH Cage.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||40 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807|
|Actual Study Start Date :||February 1, 2018|
|Actual Primary Completion Date :||February 17, 2020|
|Actual Study Completion Date :||February 17, 2020|
- Device: Conventus Cage™ PH
Proximal humeral fracture fixation
- Primary performance patient assessment [ Time Frame: Change from Baseline in Constant Murley Score at 2-year post-op ]Constant Murley Score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489408
|United States, California|
|Stanford University Hospital|
|Redwood City, California, United States, 94063|
|Torrance, California, United States, 90509|
|United States, Maryland|
|The Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|Snug Harbor Orthopedics|
|Duxbury, Massachusetts, United States, 02332|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Study Director:||Carrie Hill||Conventus Orthopaedics, Inc.|