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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 Ultrasilâ„¢. The use of this new material in its manufacturing process together with its innovative geometry, make the Primusâ„¢ 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 Primusâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primus FGTI (Flexible Great toe Implant) | Device | 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. |
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| 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". |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study has included all patients who had had a Primusâ„¢ FGT implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano FIESCHI, MD | Casa di Cura Villa Berica - Vicenza - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa Di Cura Villa Berica | Vicenza | Vicenza | 36100 | Italy |
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Recruitment period : from September 2013 to April 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Cohort | one consecutive series of patients were included |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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) |
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) |
| COMPLETED |
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| NOT COMPLETED |
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64 patients who received 70 implants (6 bilateral)
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Cohort | one consecutive series of patients were included |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | number of implants analyzed (70 implants in 64 patients) | Posted | Mean | Standard Deviation | units on a scale | mean 6.9 years follow-up (range 5.2 - 9.5) | Number of Implants | Participants |
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| Primary | 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. | Overall cohort | Posted | Mean | Standard Deviation | units on a scale | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
|
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| Primary | Pain at Passive Motion of MTP1 | Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits. | Overall cohort | Posted | Number | Number of Implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
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| Secondary | Osteolysis | Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays. | Overall cohort | Posted | Number | percentage of implants | mean 6.9 years (range, 5.5 - 9.5) | Number of Implants | Participants |
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| Secondary | Bone Resorption | Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays. | Overall cohort | Posted | Number | percentage of implants | mean 6.9 years (range, 5.5 - 9.5) | Number of Implants | Participants |
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| Primary | Pain at Pressure of MTP1 | Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits. | Overall cohort | Posted | Number | Number of Implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
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| Primary | Walking Perimeter | Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened". | Overall cohort | Posted | Number | Number of Implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
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| Primary | 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". | Overall cohort | Posted | Number | Number of Implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
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| Primary | 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". | Overall cohort | Posted | Number | Number of Implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Survival of the Implant. | The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason. | Overall cohort | Posted | Number | percentage of implants | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Number of Implants | Participants |
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Adverse events were collected throughout the longest study follow-up, i.e. 144 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Cohort | one consecutive series of patients were included | 0 | 64 | 1 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| superficial skin infection around the wound | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stefano Fieschi | Casa di Cura VIlla Berica | stefanofieschi@gmail.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
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