CTRI/2023/03/051092招募中4 期
A prospective single arm, multi-centric, post marketing clinical follow-up study to evaluate the safety and performance of pedicle screws in patient with spinal disorders
Auxein Medical Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients scheduled for pedicle screw placement surgery.
- •2. The participant can understand and provide informed consent, and has
- •signed their written informed consent.
- •3. Age between 18 - 60 years at the time of surgery
排除标准
- •1. Patients with pedicle deformity
- •2. Familial history Neurofibromatosis type 2 (NF2).
- •3. Metabolic bone disease.
- •4. History of Paget disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, Ehrlers-Danlos-
- •syndrome, osteogenesis imperfecta, achondroplasia.
- •5. History of mental disorder or current psychiatric treatment.
- •6. Pregnancy and/or female subjects intending to become pregnant
- •within the expected time frame of the study and/or female subjects of
- •child bearing age who do not use conventional contraceptive methods.
- •7. Immune deficiency disease
- •8. Scoliosis.
- •9. Lack of willingness to make a commitment to return for required follow
- •10. Drug and/or alcohol abuse.
- •11.ASA III and IV grade condition
研究者
相似试验
招募中
4 期
Study to evaluate the safety and efficacy of Ovine Forestomach Matrix (OFM) products in acute or chronic wound.CTRI/2022/01/039714Aroa Biosurgery Limited
招募中
4 期
A Study to Assess the Safety and Performance of Balloon Catheter in Superficial Femoral and Popliteal ArteriesCTRI/2024/03/063744Sahajanand Medical Technologies Limited
已完成
4 期
A scientific Study to understand the effect ofMebeverine Hydrochloride 135 mg and Chlordiazepoxide 5 mg Tablets in Indian Patientwith Management of Irritable Bowel SyndromeCTRI/2020/09/027980Abbott India Ltd60
招募中
4 期
Assessment of the clinical outcome of Bioabsorbable Ligament Anchor used in treatment of Shoulder Rotator Cuff Repair.CTRI/2022/06/043248Chetan Meditech Pvt Ltd
已完成
4 期
A Study in breast cancer patients to see how safe and effective is Dr. Reddy�s marketed drug TrastuzumabCTRI/2019/01/017214Dr Reddys Laboratories Ltd200