Evaluation of clinical performance, safety, and clinical outcome of Bone and Suture Anchor in the treatment of patients with Foot & Ankle injuries.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical Success Rate
研究概览
简要总结
The proposed, post marketing clinical follow-up study with long-term 12 month follow-up after the fixation procedures shall provide a vital evaluation assessment with regard to the implants- Peek and Titanium Anchor manufactured by Chetan Meditech Pvt. Ltd., used in the surgeons’ routine surgical procedures in foot & Ankle surgeries.
Total 100 subjects will be enrolled to achieve 80 subjects across India for indication of
-Lateral Instability repair (ATFL +/- CFL repair) (lateral ankle instability)
-Medial instability repair (Medial deltoid repair) (Medial ankle instability)
-Achilles tendon repair including Haglund’s procedure (Achilles tendon injuries)
-Suture Tape augmentation (ATFL, Medial deltoid, spring ligament (Lateral, medial and deltoid ligament injuries)
The participant will undergo the relevant surgeries as mentioned above, using the investigational device, and the study will be assessed based on primary and secondary endpoints that includes Clinical Success Rate, Visual Analogue Scale (VAS), Foot and Ankle Outcome Score (FAOS), Foot and Ankle Disability Index (FADI), Range of Motion (ROM) and record of adverse event if any.
These endpoints are used to evaluate the safety, performance of device in real world setting
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Any individual with symptomatic Foot & Ankle injuries who has failed non-operative treatment and/or require repair by surgery as per the Principal Investigator’s review.
- •Male or female subject above 18 years of age at time of surgery.
- •Subject willing to comply with all the study follow-up procedures and requirements.
- •Subjects willing to give written informed consent.
排除标准
- •Known Hypersensitivity to the implant material.
- •Patients requiring artificial ligaments to attach in Foot & Ankle injuries.
- •Patients with 2 or more failed implantation or surgical procedures in past.
- •Acute or chronic local or systemic infection.
- •Patients with insufficient or immature bone.
- •Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- •Pathological conditions of bone & soft tissue, such as osteopenia or osteoporosis.
- •Active foot ulcers or venous ulcers or diabetic foot infections or chronic venous disease.
- •Comminated bone surface which hinder the fixation capacity of implant.
- •Pregnant and lactating women.
- •Subjects with uncontrolled diabetes mellitus (Hba1c above 8.5%), and or any other severe metabolic disorders that makes the subject unfit for surgical procedure.
- •Subjects with uncontrolled hypertension (DBP more than equal to 100 mm Hg and SBP more than equal to 180 mm despite receiving medication at time of enrolment.
- •Subjects with moderate to severe liver impairment and impaired renal function.
- •Subjects with history of uncontrolled epileptic seizures.
- •Subject failed to give written consent prior to enrolment.
- •Morbid obesity.
- •(Defined as per WHO guidelines)
- •Any other ailment or disorder that is not suitable for the subject at the discretion of the investigator.
结局指标
主要结局
Clinical Success Rate
时间窗: 6 months
Clinical success is defined as foot and ankle repairs without signs of device failure and/or need of re-intervention as assessed by the surgeon.
时间窗: 6 months
次要结局
- Clinical Success Rate(12 months)
- -Visual Analogue score (VAS)(-Foot and Ankle Outcome Score (FAOS))
- -All adverse events and serious adverse event occurring during surgery or post-surgery(-Type and frequency of all reported AE/SAEs/ADE/SADE or any Device Deficiency/Device malfunction)
研究者
Dr Shakti Swaroop
The Institute of Medical Sciences and Sum Hospital