An open label pilot clinical study to assess the safety of Serioss® (SF Scaffold) in patients undergoing surgery for bone void filling.

Serigen Mediproducts Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•Patients who have been scheduled for long bone surgery requiring bone void filler. The following clinical /radiological conditions can be included:
•Orthopaedic cases: This study will recruit patients with depressed Intra articular fracture of upper end of tibia only requiring bone grafting or use of bone void fillers.
•Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects and to comply with the requirements of the entire study.
•Subject must be willing and able to give written informed consent prior to any screening procedure.
•Subject should not have any known history suggestive of hypersensitivity or allergies to the materials used in the product.
•Must be able and willing to provide written informed consent.
•Must be willing to or likely to comply with all study requirements.

•Any clinically significant medical condition e.g. active infections, cardiac, diabetes, psychiatric, neurological, pulmonary or immunological conditions etc. which may, in the judgment of the investigator, interfere with the subject’s ability to participate in the study or may interfere with study results.
•Subject should not have any clinically significant medical conditions, (including laboratory abnormalities) or disease which could jeopardize subject safety or hamper the results of the study.
•Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C.
•Pregnant women
•Known sensitivity or allergy to material used in product.
•Known allergy to silk fibroin.
•History of or current inflammatory joint disease (including RA, gout, reactive arthritis, psoriatic arthritis, seronegative, spondyloarthropathy or Lyme disease).
•History of current systemic autoimmune disorder
•History of opportunistic infection
•History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) and infected prosthetic joint.

发起方

Serigen Mediproducts Pvt Ltd