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.
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
70
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.
Casa Di Cura Villa Berica
Vicenza, Vicenza, Italy
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Osteolysis
Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.
Time frame: 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.
Time frame: 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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
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