Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02350881
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2015-01-19
Brief Title:
Mid-term Outcomes of First MTP Arthroplasty With Primus FGT Implant
Sponsor:
Stryker Trauma and Extremities
Organization:
Stryker Trauma and Extremities
Study Overview
Official Title:
A Post-Market Observational Study to Evaluate Safety and Performance of Primus FGT Implant at a Minimum of 5 Years Follow-up
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Preoperative and peroperative data were collected retrospectively
Postoperative data minimum 5 years follow-up or until implant revision were collected prospectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None