NCT02350881

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

A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an observational post-marketing surveillance study, performed by 1 (one) investigator in 1 (one) Italian site. * Preoperative and peroperative data were collected retrospectively. * Postoperative data (minimum 5 years follow-up or until implant revision) were collected prospectively.

Conditions

• Hallux Limitus of Left Great Toe
• Rheumatoid Arthritis
• Arthritis of 1st Metatarsophalangeal Joint
• Osteoarthritis
• Bunion
• Hallux Limitus of Right Great Toe

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2015-01-30
• Last updated: 2016-10-31
• Results posted: 2016-10-31

Locations

1 site across 1 country: Italy