3D Scaffold Matrix, a Class C Medical Device Bone Void Filler as a Bone Graft Substitute

Phase 2

Conditions: Health Condition 1: W183- Other and unspecified fall on samelevel

Registration Number: CTRI/2023/10/058286

Lead Sponsor: EffecMed Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Patients between the age of 18 and 65 years both inclusive with any of the following

a. Requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

b. Gap defects 6mm and 25 mm

c. Traumatic, open and closed fracture

d. Open and closed fractures - traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 and B3)

e. Cavitary defects in benign and low-grade malignant bone tumours.

f. Bone void created during surgery.

g. Bone disease i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget disease

2. Negative for HIV and HBsAg.

3. Written informed consent obtained before any study-related activities.

4. Communicative ability to understand the procedure and participate in the study and comply with the follow up.

Exclusion Criteria

Patient will be excluded from the study, if they have any of the following

1. Critical size defect below 5 mm

2. Critical size defect more than 26 mm

3. Polytrauma bone injuries

4. Excessive destruction of bone through and through defects, excessive thinning of lower border

5. Injury leading to debridement interval more than 12 h

6. Compartment syndrome

7. Pathologic fracture

8. Chronic pain disease

9. Malignancy

10. Chronic cortisone intake

11. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation

12. Pre-existing calcium metabolism disorder Hypercalcemia

13. Known hyperthyroidism or autonomous thyroid adenoma

14. Irreversible coagulopathy or bleeding disorder

15. Metastatic cancer

16. Active infection at the site of implantation

17. History of bone marrow disorders

18. Active malignancy, cellulitis, osteomyelitis, bone metastasis, and other bone metabolic diseases.

19.Primary bone tumour and contraindications in performing an Xray or CT scan

20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study.

21.With known autoimmune disease, such as Addison disease, Myasthenia gravis, Pernicious anaemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Dermatomyositis, Grave disease, Hashimotos thyroiditis, and Type 1 diabetes mellitus.

22. Physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications.

23. Concurrently participating in other clinical trials or within last 1 month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome (fracture healing) is assessed objectively by radiography (plain and CT) by an Efficacy Endpoint Assessment and Adjudication Group independent of the study. <br/ ><br> <br/ ><br>1)Time to radiographic healing <br/ ><br>2)Bone healing and recoveryTimepoint: Preoperative at Screening/ Baseline, and post-operative at end of Week 1, Month 1, Month 3 and Month 6

Secondary Outcome Measures

Name	Time	Method
1)Visual Analog Scale for Pain at site of injury/ implantation. <br/ ><br>2)Function IndeX for Trauma scale (FIX-IT) assessment <br/ ><br>3)Disability Rating Index c <br/ ><br>4)12-Item Short Form (SF-12v2®) Health Survey score <br/ ><br>5)Visual Analog Scale for Investigator’s Satisfaction with the Product: Satisfaction with product <br/ ><br>6)Laboratory investigations <br/ ><br>7)Incidence of (number and description) adverse events, serious adverse events, device complaints and device-related incidents. <br/ ><br>8)Secondary intervention (surgical or nonsurgical) <br/ ><br>9)Surgical site infectionTimepoint: Preoperatively at Screening/ Baseline, and post-operative at end of Week 1, Month 1, Month 3 and Month 6