A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain at Rest
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patient does not have clinical and radiographic follow-up data available.
研究组 & 干预措施
未命名试验
干预措施: Primus FGTI (Flexible Great toe Implant) (Device)
结局指标
主要结局
Pain at Rest
时间窗: 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".
AOFAS Hallux-MTP-IP Score - Overall
时间窗: 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".
Pain at Pressure of MTP1
时间窗: 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
时间窗: 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".
AOFAS Hallux-MTP-IP - PAIN Score
时间窗: 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
时间窗: 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.
Pain During Walking
时间窗: 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".
次要结局
- Osteolysis(mean 6.9 years (range, 5.5 - 9.5))
- Survival of the Implant.(mean follow-up of 6.9 years (range, 5.2 - 9.5))
- Bone Resorption(mean 6.9 years (range, 5.5 - 9.5))