The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 8
- 主要终点
- Fusion
研究概览
简要总结
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients of at least 18 years old
- •Patient suffering from a spinal degenerative disease.
- •Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease
- •Patient implanted with MEDICREA's products, or patients who are candidate to receive including at least the PASS LP and/or PASS DEGEN and/or PASS TULIP Prime implants
- •Patient affiliated to a national insurance system
排除标准
- •Patient unable or unwilling to sign and understand an information note with proof of patient consent
- •Patient unable to complete a self-administered questionnaire
- •Patient presenting contra-indications to a Xray follow-up
- •Patient of more than 18 years old under a protection procedure
- •Patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years
研究组 & 干预措施
PASS Degen implants
Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN
干预措施: PASS DEGEN (Device)
PASS Tulip PRIME implants
Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME
干预措施: PASS TULIP PRIME (Device)
PASS LP implants
Patient suffering from a spinal degenerative disease and who is operated with PASS LP
干预措施: PASS LP implants (Device)
结局指标
主要结局
Fusion
时间窗: At 24months
The primary endpoint is the fusion status of each patient at the 24-month visit postoperative. This fusion assessment will be done through the analysis of the standard of care imaging (CT-scan, X-rays, and/or MRI) by the investigator and through the clinical examination of the patient by the investigator.
Number of Participant Who Achieved Their Fusion at 24 Months
时间窗: At 24months
The primary endpoint is the fusion status of each patient at the 24-month visit postoperative. This fusion assessment will be done through the analysis of the standard of care imaging (CT-scan, X-rays, and/or MRI) by the investigator and through the clinical examination of the patient by the investigator.
次要结局
- Quality of life with SF-12(Preoperative, and 1-6, 12 and 24 months postoperative)
- Surgeons'satisfaction with these implants and instruments(During the surgery and until the 24months postoperative visit)
- Fusion status at the 1/6 month and 12-month visit(At the 1-6, and 12 months postoperative)
- Device or procedure-related adverse events and all SAEs up to 24 months(Preoperative, and 1-6, 12 and 24 months postoperative)
- Evolution of the pain (VAS)(Preoperative, and 1-6, 12 and 24 months postoperative)
- Patient satisfaction at all available postoperative timepoints(At 1-6, 12 and 24 months postoperative)
- Quality of life with ODI(Preoperative, and 1-6, 12 and 24 months postoperative)
- Evolution of the Pain (VAS)(Preoperative, and 1-6, 12 and 24 months postoperative)
- Quality of Life With ODI(Preoperative, and 1-6, 12 and 24 months postoperative)
- Quality of Life With SF-12(Preoperative, and 1-6, 12 and 24 months postoperative)
- Surgeons'Satisfaction With These Implants and Instruments(During the surgery and until the 24months postoperative visit)
- Fusion Status at the 1/6 Month and 12-month Visit(At the 1-6, and 12 months postoperative)
- Patient Satisfaction at All Available Postoperative Timepoints(At 1-6, 12 and 24 months postoperative)