A Post-Marketing Observational Study to Evaluate Primus™ FGT Implant at a Minimum of 5 Years Follow-up

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350881
• Other study ID #: 1202-T-FGTI-M
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 26, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéItaly: Ethics Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Arthritis, Rheumatoid
• Geriatric Bunion
• Hallux Abducto Valgus Associated With Arthritis
• Hallux Limitus
• Hallux Limitus or Hallux Rigidus
• Hallux Rigidus
• Rheumatoid Arthritis
• Symptomatic Grade II or III Osteoarthritis
• Unstable or Painful Joint From Previous Surgery

Intervention

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.

Locations

Country	Name	City	State
Italy	Casa Di Cura Villa Berica	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Tornier, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score	Pain : 40/100 points; Function : 45/100 points; Alignment : 15/100 points; TOTAL : 100 points	5-year minimum follow-up	No
Primary	Clinical evaluation of MTP1 pain and function	Pain at passive motion of MTP1 : absent / moderate / severe; Pain at pressure on MTP1 : absent / moderate / severe; Swelling : absent / moderate / severe; Metatarsalgia : absent / moderate / severe	5-year minimum follow-up	No
Primary	Subjective patient satisfaction	Walking perimeter : improved / same / worsened; Pain during walking : Disappeared / less / same / greater; Pain at rest : Disappeared / less / same / greater	5-year minimum follow-up	No
Secondary	Evaluation of long-term radiological outcomes in terms of osteolysis, and bone resorption.	Objective radiological evaluation (postoperative); Osteolysis evaluation : absence / presence; Bone resorption : absence / presence Radiological evaluations were done from available frontal and lateral view X-rays.	5-year minimum follow-up	No
Secondary	Evaluation of safety and survivorship of the implant.	Safety data will be collected: nature of complications related to Primus™ FGT implantation,; nature, incidence and severity of Adverse Device Effects,; nature and incidence of all medical/surgical interventions occurring which are related to Primus™ FGT,; all arthroplasty re-interventions.	5-year minimum follow-up	Yes