Arthritis of 1st Metatarsophalangeal Joint, Bunion, Hallux Limitus of Left Great Toe, Hallux Limitus of Right Great Toe, Osteoarthritis, Rheumatoid Arthritis
Conditions
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 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.
Interventions
DEVICEPrimus FGTI (Flexible Great toe Implant)
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.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater. |
| Pain at Pressure of MTP1 | 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 | 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. |
| Pain During Walking | mean follow-up of 6.9 years (range, 5.2 - 9.5) | Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater. |
| AOFAS Hallux-MTP-IP Score - Overall | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Resorption | 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. | 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. |
| Osteolysis | 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. |
Countries
Italy
Participant flow
Recruitment details
Recruitment period : from September 2013 to April 2014
Participants by arm
| Arm | Count |
|---|---|
| Overall Cohort one consecutive series of patients were included | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | Overall Cohort |
|---|---|
| Age, Continuous | 59.8 years |
| Region of Enrollment Italy | 64 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Population: Overall cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Cohort | AOFAS Hallux-MTP-IP - PAIN Score | 35.4 units on a scale | Standard Deviation 5 |
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.
Time frame: mean 6.9 years follow-up (range 5.2 - 9.5)
Population: number of implants analyzed (70 implants in 64 patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Cohort | AOFAS Hallux-MTP-IP Score - Overall | 88.9 units on a scale | Standard Deviation 9.1 |
Primary
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)
Population: Overall cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Cohort | Pain at Passive Motion of MTP1 | Preoperative | 0 Number of Implants |
| Overall Cohort | Pain at Passive Motion of MTP1 | Postoperative | 65 Number of Implants |
| Moderate | Pain at Passive Motion of MTP1 | Preoperative | 6 Number of Implants |
| Moderate | Pain at Passive Motion of MTP1 | Postoperative | 3 Number of Implants |
| Severe | Pain at Passive Motion of MTP1 | Postoperative | 2 Number of Implants |
| Severe | Pain at Passive Motion of MTP1 | Preoperative | 64 Number of Implants |
Primary
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)
Population: Overall cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Cohort | Pain at Pressure of MTP1 | Preperative | 0 Number of Implants |
| Overall Cohort | Pain at Pressure of MTP1 | Postoperative | 61 Number of Implants |
| Moderate | Pain at Pressure of MTP1 | Preperative | 16 Number of Implants |
| Moderate | Pain at Pressure of MTP1 | Postoperative | 8 Number of Implants |
| Severe | Pain at Pressure of MTP1 | Preperative | 54 Number of Implants |
| Severe | Pain at Pressure of MTP1 | Postoperative | 1 Number of Implants |
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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Pain at Rest | 61 Number of Implants |
| Moderate | Pain at Rest | 9 Number of Implants |
| Severe | Pain at Rest | 0 Number of Implants |
| Greater | Pain at Rest | 0 Number of Implants |
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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Pain During Walking | 55 Number of Implants |
| Moderate | Pain During Walking | 15 Number of Implants |
| Severe | Pain During Walking | 0 Number of Implants |
| Greater | Pain During Walking | 0 Number of Implants |
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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Walking Perimeter | 59 Number of Implants |
| Moderate | Walking Perimeter | 11 Number of Implants |
| Severe | Walking Perimeter | 0 Number of Implants |
Secondary
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)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Bone Resorption | 64.3 percentage of implants |
| Moderate | Bone Resorption | 35.7 percentage of implants |
Secondary
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)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Osteolysis | 81.4 percentage of implants |
| Moderate | Osteolysis | 18.6 percentage of implants |
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.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Population: Overall cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Survival of the Implant. | 100 percentage of implants |
| Moderate | Survival of the Implant. | 0 percentage of implants |