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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Bunion; Hallux Limitus of Left Great Toe; Arthritis of 1st Metatarsophalangeal Joint; Hallux Limitus of Right Great Toe
• Intervention / Treatment: Device: Primus FGTI (Flexible Great toe Implant)

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Italy
  • Vicenza, Italy, 36100
    • Casa Di Cura Villa Berica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study has included all patients who had had a Primus™ FGT implantation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS Hallux-MTP-IP Score - Overall	AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered "good", below 20 points as "bad".	mean 6.9 years follow-up (range 5.2 - 9.5)
AOFAS Hallux-MTP-IP - PAIN Score	Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.	mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Passive Motion of MTP1	Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.	mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Pressure of MTP1	Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.	mean follow-up of 6.9 years (range, 5.2 - 9.5)
Walking Perimeter	Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".	mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain During Walking	Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", same", "greater".	mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Rest	Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", "same, "greater".	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteolysis	Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.	mean 6.9 years (range, 5.5 - 9.5)
Bone Resorption	Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.	mean 6.9 years (range, 5.5 - 9.5)
Survival of the Implant.	The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Principal Investigator: Stefano FIESCHI, MD, Casa di Cura Villa Berica - Vicenza - Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Arthritis; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: 1202-T-FGTI-M