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

Stryker Trauma and Extremities

Status: Completed

Conditions: Hallux Limitus of Left Great Toe; Osteoarthritis; Bunion; Arthritis of 1st Metatarsophalangeal Joint; Hallux Limitus of Right Great Toe; Rheumatoid Arthritis

Treatments: Device: Primus FGTI (Flexible Great toe Implant)

Study type: Observational

Funder types: Industry

Identifiers

NCT02350881

1202-T-FGTI-M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient has had a Primus™ FGT implantation for one of the following indications: hallux limitus, hallux rigidus, hallux abducto valgus associated with severe arthritis, unstable or painful joint from previous surgery on the great toe,
• patient having all necessary clinical and radiographical data available.,
• patient has been informed about this scientific study and has provided their Consent to participate.

Exclusion criteria

• patient does not have clinical and radiographic follow-up data available.