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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 Summary:

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.

Sponsor: Tornier, Inc.

Current Primary Outcome:

  • AOFAS Hallux-MTP-IP Score - Overall [ Time Frame: mean 6.9 years follow-up (range 5.2 - 9.5) ]
    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".
  • AOFAS Hallux-MTP-IP - PAIN Score [ Time Frame: mean follow-up of 6.9 years (range, 5.2 - 9.5) ]
    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.
  • Pain at Passive Motion of MTP1 [ Time Frame: mean follow-up of 6.9 years (range, 5.2 - 9.5) ]
    Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.
  • Pain at Pressure of MTP1 [ Time Frame: mean follow-up of 6.9 years (range, 5.2 - 9.5) ]
    Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.
  • Walking Perimeter [ Time Frame: mean follow-up of 6.9 years (range, 5.2 - 9.5) ]
    Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".

    Original Primary Outcome:

    • AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score [ Time Frame: 5-year minimum follow-up ]
      • Pain : 40/100 points
      • Function : 45/100 points
      • Alignment : 15/100 points
      • TOTAL : 100 points
    • Clinical evaluation of MTP1 pain and function [ Time Frame: 5-year minimum follow-up ]
      • 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
    • Subjective patient satisfaction [ Time Frame: 5-year minimum follow-up ]
      • Walking perimeter : improved / same / worsened
      • Pain during walking : Disappeared / less / same / greater
      • Pain at rest : Disappeared / less / same / greater


    Current Secondary Outcome:

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


    Original Secondary Outcome:

    • Evaluation of long-term radiological outcomes in terms of osteolysis, and bone resorption. [ Time Frame: 5-year minimum follow-up ]

      Objective radiological evaluation (postoperative)

      • Osteolysis evaluation : absence / presence
      • Bone resorption : absence / presence Radiological evaluations were done from available frontal and lateral view X-rays.
    • Evaluation of safety and survivorship of the implant. [ Time Frame: 5-year minimum follow-up ]

      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.


    Information By: Tornier, Inc.

    Dates:
    Date Received: January 19, 2015
    Date Started: May 2013
    Date Completion:
    Last Updated: September 12, 2016
    Last Verified: May 2016