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Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.

NCT02350881 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2016-10-31

Study results available
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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.

Conditions

Interventions

DEVICE

Primus FGTI (Flexible Great toe Implant)

Great toe arthroplasty consists of replacing the first Meta-Tarso-Phalangeal (MTP1) joint by a two hinged prosthesis made of silicone : the Primus FGT implant (FGTI). The Primus is designed with an axially offset hinge to align with the anatomy of the MTP joint. This results in less implant stresses and improved toe function.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Stefano FIESCHI, MD · Casa di Cura Villa Berica - Vicenza - Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-06-30
Completion
2014-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350881 on ClinicalTrials.gov