Evaluation of Clinical Performance Safety and Clinical Outcome of Bone and Suture Anchor in the Treatment of Patients with Hand & Wrist Injuries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
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 Anchor manufactured by Chetan Meditech Pvt. Ltd., used in the surgeons’ routine surgical procedures in hand & wrist surgeries.
Total 100 subjects will be enrolled to achieve 80 subjects across India for indication of
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Collateral ligament repair of hand and finger joints Volar plate/ capsular repair and reconstruction Volar repair/ reconstruction, Flexor and extensor tendon repair /reconstruction
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Triangular Fibro-cartilage Complex (TFCC) repair
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Scapho-lunate (SL) ligament repair
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Distal radio-ulnar joint (DRUJ) repair
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), Quick- Disabilities of the arm, shoulder and hand (QDASH), Range of Motion (ROM-wrist and fingers), Pinch strength, Grip strength, Mayo Wrist Score and record of adverse event if any.
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 hand & wrist injuries who has failed non-operative 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.
- •Subjects 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 Hand and wrist 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 and osteoporosis.
- •Active ulcers/ venous ulcers/diabetic infections/ chronic venous disease.
- •Pregnant and lactating women.
- •Subjects with uncontrolled diabetes mellitus (Hba1c above 8.5 percent), and/ or any other severe metabolic disorders that makes the Subject unfit for surgical procedure.
- •Subjects with uncontrolled hypertension (DBP greater or equal to 100 mm Hg and SBP greater or 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.
- •Any other ailment/disorder that is not suitable for the subject at the discretion of the investigator.
- •Subject failed to give written consent prior to enrolment.
- •Morbid obesity.
- •(defined as per WHO guidelines).
研究者
Dr Abhijeet Wahegaonkar
SAHYADRI HOSPITAL PVT. LTD.