CTRI/2022/07/044291
Recruiting
未知
A prospective, single-centre, non- randomised pilot clinical study to evaluate the safety and efficacyof biodegradable NANOTEX BONE graft (Nanocomposite Fibrous Scaffold) along with fibula flap inreconstruction of segmental mandibular defect due to tumour resection or trauma
Amrita Vishwa Vidyapeetham Amrita Institute of Medical Sciences0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: C00-D49- Neoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Sponsor
- Amrita Vishwa Vidyapeetham Amrita Institute of Medical Sciences
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •2\.Segmental Mandibular defect due to resection of benign tumour or trauma
- •3\.A female patient is eligible to participate if she is not pregnant, not breastfeeding
- •4\.Patient must be available at the study centre for all specified assessments throughout the study duration.
- •5\.Patients whose clinical laboratory test results are within the reference range for healthy individuals, or where outside the reference range is judged as not clinically relevant by the Investigator
Exclusion Criteria
- •\-Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation.
- •\-Mandibular ramus defects with open wounds.
- •\-Systemic disease that would affect the surgical procedure and implant integration along with associated anesthesia, unsafe to the patient.
- •\-Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data
- •\-Active uncontrolled infection or malignancy.
- •\-Patients indicated for radiotherapy before and after surgery
- •\-Patients participated in any other clinical trial in past 1 month, or currently participating in any other clinical trial.
- •\-Conditions that may impact the success of the surgical implantation or increase the risk of postoperative complications, including inherited coagulopathies like hemophilia, Von Wille brand s disease, protein C
- •and S deficiency, thrombocythemias, thallassemias, sickle cell disease, etc.
- •\-Conditions that may impact functional outcomes, including uncontrolled diabetes, osteoporosis, rare disorders of bone healing like osteopetrosis, or any other metabolic bone disease.
Outcomes
Primary Outcomes
Not specified
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