An observational study in Hallux Limitus of Left Great Toe, Rheumatoid Arthritis and Arthritis of 1st Metatarsophalangeal Joint, sponsored by Stryker Trauma and Extremities. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Stryker Trauma and Extremities · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 70 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study has included all patients who had had a Primus™ FGT implantation.
Exclusion Criteria:
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.
Also known as: First metatarsophalangeal arthroplasty
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)
Recruitment period : from September 2013 to April 2014
| Milestone | Overall Cohort |
|---|---|
| Started | 64 |
| Completed | 64 |
| Not completed | 0 |
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".
| units on a scale | Overall Cohort |
|---|---|
| AOFAS Hallux-MTP-IP Score - Overall | 88.9 ± 9.1 |
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.
| units on a scale | Overall Cohort |
|---|---|
| AOFAS Hallux-MTP-IP - PAIN Score | 35.4 ± 5.0 |
Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.
| Number of Implants | Absent | Moderate | Severe |
|---|---|---|---|
| Preoperative | 0 | 6 | 64 |
| Postoperative | 65 | 3 | 2 |
Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.
| percentage of implants | Absence | Presence |
|---|---|---|
| Osteolysis | 81.4 | 18.6 |
Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.
| percentage of implants | Absence | Presence |
|---|---|---|
| Bone Resorption | 64.3 | 35.7 |
Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.
| Number of Implants | Absent | Moderate | Severe |
|---|---|---|---|
| Preperative | 0 | 16 | 54 |
| Postoperative | 61 | 8 | 1 |
Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".
| Number of Implants | Improved | Same | Worsened |
|---|---|---|---|
| Walking Perimeter | 59 | 11 | 0 |
Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", same", "greater".
| Number of Implants | Disappeared | Less | Same | Greater |
|---|---|---|---|---|
| Pain During Walking | 55 | 15 | 0 | 0 |
Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", "same, "greater".
| Number of Implants | Disappeared | Less | Same | Greater |
|---|---|---|---|---|
| Pain at Rest | 61 | 9 | 0 | 0 |
The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.
| percentage of implants | Survival | Revisions |
|---|---|---|
| Survival of the Implant. | 100 | 0 |
Collected over Adverse events were collected throughout the longest study follow-up, i.e. 144 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Cohort | — | 0/64 (0%) | 1/64 (1.6%) |
| Event | Overall Cohort |
|---|---|
| superficial skin infection around the woundInfections and infestations | 1/64 |
64 patients who received 70 implants (6 bilateral)
| Age, Continuous(years) | Overall Cohort |
|---|---|
| Mean | 59.8 (45 to 77) |
| Sex: Female, Male(Participants) | Overall Cohort |
|---|---|
| Female | 46 |
| Male | 18 |
| Region of Enrollment(participants) | Overall Cohort |
|---|---|
| Italy | 64 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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