The study to assess the safety of Serioss® (SF Scaffold) in patients.
- Conditions
- Health Condition 1: S821- Fracture of upper end of tibiaHealth Condition 2: S821- Fracture of upper end of tibiaHealth Condition 3: S00-T88- Injury, poisoning and certain other consequences of external causes
- Registration Number
- CTRI/2021/01/030589
- Lead Sponsor
- Serigen Mediproducts Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the safety of Serioss® (SF scaffold) for human useTimepoint: At visit 2, Visit 3,Visit 4, Visit 5, Visit 6,Visit 7
- Secondary Outcome Measures
Name Time Method To assess effects of Serioss® (SF scaffold), implantation in patients undergoing surgery for bone grafting.Timepoint: From Visit 1 to Visit 7