Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03290586|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment|
|First Metatarsophalangeal Joint Arthritis||Device: Flower Cube|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||April 30, 2018|
- Device: Flower Cube
single use, sterile disposable fixation construct
- Union Rates [ Time Frame: 12 months ]Confirm union rates comparable to existing outcomes complications with our proposed construct.
- Hardware Failures [ Time Frame: 12 months ]Evaluate hardware failures with our proposed construct.
- Complications [ Time Frame: 12 months ]Evaluate complications with the procedure
- Cost Data [ Time Frame: 12 months ]Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting.
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): NCT03290586
|Contact: John Levin, DPMfirstname.lastname@example.org|
|Contact: Melissa Daggerhart, MBAemail@example.com|
|United States, Florida|
|JEM Research Institute||Recruiting|
|Atlantis, Florida, United States, 33462|
|Contact: John Levin, DPM 561-968-2933|
|Contact: Melissa Daggerhart, MBA 561-968-2933|
|Principal Investigator:||John Levin, DPM||JEM Research Institute|