Prospective Clinical Study of Tri-planar TarsometatarsL (TMT) ArthrodesIs with Early Weight-Bearing after Lapiplasty Procedure
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- STATUS
- Recruiting
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- participants needed
- 40
Summary
People may participate in this study if their study doctor has determined that they have a type of bunion that could benefit from a bunion correction procedure called the Lapiplasty Procedure. The purpose of this clinical study is to collect information on patients in need of bunion correction surgery that have their bunion surgically corrected with the Lapiplasty procedure. This study will collect information on how well the Lapiplasty procedure fixes the bunion and how often a bunion recurs after this procedure. The study will also determine if putting weight on your foot shortly after surgery affects how well your bone heals (fuse) after the Lapiplasty procedure. Information about pain caused by the bunion and how whether your pain improves and your satisfaction with the procedure will also be collected throughout the study.
Description
The Plating System and Screw System is used in stabilizing (fixing) the joint, so the bones can fuse. The Lapiplasty Procedure is designed to restore the natural anatomy of your toe without cutting and shifting the bones of your toe. The bone is rotated and shifted back into place and eliminates the bump that is found with a bunion. The toe joint is then permanently secured with the metal plates and screws.
FAQ
Details
| Condition | bunion |
|---|---|
| Age | 18years - 90years |
| Clinical Study Identifier | TX6278 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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