Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

A First-in-human Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.

Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin.

As per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery.

Inclusion Criteria:

1. Male or female patients within the age range of ≥18 years to ≤80 years.

2. Patient diagnosed with DRF with confirmed:

   1. Classification AO/ATO: C2 and C3 - Intra-articular & multifragmentation.
   2. Estimated volume of the targeted bone void should not exceed 5cc.
   3. Availability of diagnostic AP and LAT X-ray or CT scan.

3. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.

4. Patient fulfills criteria for undergoing a surgical intervention.

5. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.

Exclusion Criteria:

1. Open DRF or closed DRF with increased infection risk.

2. Injury to the median nerve.

3. Previous fracture of the target distal radius.

4. Documented disease limiting mobility and functional assessments (eg. Grip strength test).

5. Dependency on crutches or any comparable walking aids.

6. Patient is overweight, has a BMI ≥35.

7. Presence of clinically significant infection at the target implant site or systemic infection.

8. History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:

   1. Osteosynthesis materials (PEEK plate and screws).
   2. Anesthetic agents.
   3. Components of the NVDX3 implant.

9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.

10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.

11. Presence of an active tumor.

12. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism.

13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.

14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.

15. Any history of experimental therapy with another investigational drug within 60 days prior to screening.

16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study.

17. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.

18. Patient with historically elevated radiation exposure levels that could in the opinion of the investigator have introduced unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.