Post-Market Clinical Follow-up Study – Prospective Evaluation of data for the ROCCIA® TLIF sytem - PMCF ROCCIA® TLIF system
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
A total of 81 patients were included in the PMCF study, whereby 11 patients were subsequently excluded due to not meeting the inclusion criteria. This final PMCF study report therefore includes data from a total of 70 patients. The response rate for the primary endpoint ODI is 85.7% at 12 months FU. The primary objective of the PMCF study is to demonstrate the clinical benefit for patients in the form of pain reduction using the Oswestry Disability Index (ODI) score in a comparison between pre-op and post-op (4 months FU and 12 months FU). Furthermore, the clinical safety and performance as well as the justifiability of the known risks should be ensured and potential risks/side effects should be recognized at an early stage (number and type of complications, as well as the number and reason for revisions). number and reason for revisions). The data show a significant reduction in limitations and improvement in quality of life after surgery with the ROCCIA® TLIF Cage System based on the comparison of the ODI and EQ-5D-5L values pre-op with the values at 4 and 12 months FU (p<0.001). Furthermore, the evaluation of the VAS back and VAS leg shows significant reductions (p<0.001) in back and leg pain after surgery with the ROCCIA® TLIF Cage System at all postoperative time points (discharge, 4 months FU and 12 months FU). The proportion of patients with neurological deficits decreased from 12.9% pre-op to 7.1% at discharge, 6.3% at 4 months FU and 1.9% at 12 months FU. The measurement of the X-ray data shows, in line with current literature, that the segmental and lumbar lordosis can be corrected in mono- and bisegmentally treated patients using the TLIF technique with the ROCCIA® TLIF system and that the result can be maintained without any relevant loss of correction. can be maintained without relevant loss of correction. None of the patients were diagnosed by the investigator with signs of cage migration or implant failure based on evaluation of the X-ray images. The incidences of intraoperative and postoperative complications were 8.6% and 7.1% respectively. The revision rate was 5.7% (4 patients with one revision each). According to the assessment of the investigator and manufacturer, no implant-related intraoperative or postoperative complications were recorded. In addition, the evaluation of the intraoperative and postoperative postoperative complications shows that no product defects of the ROCCIA® TLIF Cage System occurred during the PMCF study. The data from this PMCF study therefore show that the ROCCIA® TLIF Cage System provides significant clinical benefits for the patient and thus fulfills the requirements for clinical safety and performance.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •The ability to read, understand and speak the local language fluently
- •Signed consent form
- •The surgical indication must be one or a combination of the following.
- •o Degenerative disc disease
- •o Deformities
- •o Segmental dysfunction of the lumbar spine or thoracolumbar spine, if applicable
- •o Spondylolisthesis
- •o Segmental instability
- •1-2 level OPs (L1-S1)
- •Age: 18-75 years
排除标准
- •segmental supply of 3 or more levels
- •Contraindications
- •Absolute contraindications
- •- Expected or documented allergy or intolerance to the materials (e.g. titanium).
- •- Any case in which the selected implants would be too large or too small to achieve a successful result.
- •- Any patient in whom the use of the implant would conflict with the anatomical structures.
- •- Missing bony structures that make good anchorage of the implant impossible (e.g. fractures, tumors, osteoporosis or infections).
- •Relative contraindications
- •- Overweight of the patient
- •- deformities
- •- Fever or leukocytosis
- •- Systemic diseases and metabolic disorders
- •- Unbalanced diet, drug abuse, nicotine, alcohol, drug consumption
- •- Physical activities involving strong shocks, where the implant is exposed to blows and/or excessive stress (e.g., heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports).
- •- Patient who is mentally incapable of understanding and following the physician's instructions.
- •- Operations on pregnant women are to be avoided if possible or require special Care or procedure. This is at the discretion of the surgeon.
- •- Any condition that might preclude the potential benefit of spinal implantation should be clarified by the applying physician. These could be: tumors, local fractures in the area of the surgical site, unexplained increase in erythrocyte sedimentation rate
- •due to other diseases, increase in leukocytes or a significant shift in the differential blood count or other parameters.