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Clinical Trial Summary

Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants. Allergies to silicone, infections due to silicone and implants breakage used to be common with previous generations of silicone implants. Publications relative to those implants showed that the survival rates after 5 years of follow-up were unsatisfactory.

Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™. The use of this new material in its manufacturing process together with its innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant.

The main objective of this study is to evaluate the clinical outcomes of the implantation of Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in terms of functional metrics from documented clinical data. Other objectives are to evaluate the outcomes in terms of radiological evaluation and of safety during all the follow-up.


Clinical Trial Description

This is an observational post-marketing surveillance study, performed by 1 (one) investigator in 1 (one) Italian site.

Preoperative and perioperative data will be collected retrospectively. Data at a minimum of 5 years after the surgery - or until implant revision - will be collected prospectively. ;


Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


NCT number NCT02350881
Study type Observational
Source Tornier, Inc.
Contact
Status Completed
Phase N/A
Start date May 2013
Completion date November 2014

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