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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Drug: NVDX3

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVDX3 implant	Drug: NVDX3; NVDX3 is implanted during a single surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs	Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs	Between the beginning of the implant surgery (IS) and 12 months post-IS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Serious TEAEs and NVDX3-related TEAEs	Number of participants with serious TEAEs and NVDX3-related TEAEs	Between the beginning of IS and 6 weeks post-IS
Safety: Serious TEAEs and NVDX3-related TEAEs	Number of participants with serious TEAEs and NVDX3-related TEAEs	Beyond 6 weeks post-IS till 12 months post-IS
Safety: TEAEs	Number of participants with TEAEs	Between the beginning of IS and 6 weeks post-IS Beyond 6 weeks post-IS till 12 months post-IS Between the beginning of IS and 12 months post-IS
Safety: Related and Unexpected TEAEs and Serious TEAEs	Number of participants with related and unexpected TEAEs and serious TEAEs	Between the beginning of IS and 12 months post-IS
Safety: TEAEs of Special Interest	Number of participants with TEAEs of Special Interest	Between the beginning of IS and 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.	At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.	At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.	At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation	Radiological assessments on X-ray data using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation	At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union	At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling	At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.	At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.	At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.	At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.	At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score	Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.	At 12 months post-IS
Efficacy: Clinical Assessments - Grip Strength	Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)	At 2 weeks post-IS
Efficacy: Clinical Assessments - Grip Strength	Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)	At 6 weeks post-IS
Efficacy: Clinical Assessments - Grip Strength	Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)	At 3 months post-IS
Efficacy: Clinical Assessments - Grip Strength	Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)	At 6 months post-IS
Efficacy: Clinical Assessments - Grip Strength	Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)	At 12 months post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At Hospital Discharge
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At 2 weeks post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At 6 weeks post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At 3 months post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At 6 months post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)	Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.	At 12 months post-IS
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)	PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.	At 2 weeks post-IS
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)	PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.	At 6 weeks post-IS
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)	PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.	At 3 months post-IS
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)	PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.	At 6 months post-IS
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)	PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.	At 12 months post-IS
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At hospital discharge
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At 2 weeks post-IS
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At 6 weeks post-IS
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At 3 months post-IS
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At 6 months post-IS
Efficacy: NRS-pain	NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).	At 12 months post-IS

Collaborators and Investigators

• Sponsor: Novadip Biosciences
• Collaborators: PrimeVigilance; Data Investigation Company Europe (DICE)
• Investigators: Principal Investigator: Torsten Gerich, MD, Centre Hospitalier du Luxembourg

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures
• Other Study ID Numbers: NVDX3-CLN01; 2022-002304-21 (EudraCT Number); 2023-508321-27-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No