N/A
N=64
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Hallux Limitus of Left Great Toe · Rheumatoid Arthritis · Arthritis of 1st Metatarsophalangeal Joint · Osteoarthritis · Bunion
Bottom Line
View on ClinicalTrials.gov: NCT02350881 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: AOFAS Hallux-MTP-IP Score - Overall — 88.9 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Primus FGTI (Flexible Great toe Implant) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Trauma and Extremities
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AOFAS Hallux-MTP-IP Score - Overall |
88.9 | — |
| PRIMARY AOFAS Hallux-MTP-IP - PAIN Score |
35.4 | — |
| PRIMARY Pain at Passive Motion of MTP1 |
0; 6; 64; 65; 3; 2 | — |
| PRIMARY Pain at Pressure of MTP1 |
0; 16; 54; 61; 8; 1 | — |
| PRIMARY Walking Perimeter |
59; 11; 0 | — |
| PRIMARY Pain During Walking |
55; 15; 0; 0 | — |
| PRIMARY Pain at Rest |
61; 9; 0; 0 | — |
| SECONDARY Osteolysis |
81.4; 18.6 | — |
| SECONDARY Bone Resorption |
64.3; 35.7 | — |
| SECONDARY Survival of the Implant. |
100; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02350881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.