Clinical trial NCT02350881: Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Official title: A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Limitus of Left Great Toe
Rheumatoid Arthritis
Arthritis of 1st Metatarsophalangeal Joint
Osteoarthritis
Bunion
Hallux Limitus of Right Great Toe
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study has included all patients who had had a Primus™ FGT implantation.

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.

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.

Primary outcomes:
measure: AOFAS Hallux-MTP-IP Score - Overall
timeFrame: mean 6.9 years follow-up (range 5.2 - 9.5)
measure: AOFAS Hallux-MTP-IP - PAIN Score
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
measure: Pain at Passive Motion of MTP1
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
measure: Pain at Pressure of MTP1
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
measure: Walking Perimeter
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
measure: Pain During Walking
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
measure: Pain at Rest
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Secondary outcomes:
measure: Osteolysis
timeFrame: mean 6.9 years (range, 5.5 - 9.5)
measure: Bone Resorption
timeFrame: mean 6.9 years (range, 5.5 - 9.5)
measure: Survival of the Implant.
timeFrame: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Other outcomes:
Locations:
city: Vicenza
country: Italy
facility: Casa Di Cura Villa Berica
Study officials:
affiliation: Casa di Cura Villa Berica - Vicenza - Italy
name: Stefano FIESCHI, MD
role: PRINCIPAL_INVESTIGATOR
References: