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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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First metatarsophalangeal arthroplasty

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano FIESCHI, MD

Role: PRINCIPAL_INVESTIGATOR

Casa di Cura Villa Berica - Vicenza - Italy

Locations

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Casa Di Cura Villa Berica

Vicenza, Vicenza, Italy

Site Status

Countries

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Italy

Other Identifiers

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1202-T-FGTI-M

Identifier Type: -

Identifier Source: org_study_id