Distal Radius FracturesPhase 1/2NCT05987033
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
A Phase 1/2 study testing NVDX3 in people with Distal Radius Fractures, run by Novadip Biosciences at 1 site in Luxembourg.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- NVDX3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteLuxembourg
- Study dates
- 8 Aug 2023to 19 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients within the age range of ≥18 years to ≤80 years.
- Patient diagnosed with DRF with confirmed:
- Classification AO/ATO: C2 and C3 - Intra-articular \& multifragmentation.
- Estimated volume of the targeted bone void should not exceed 5cc.
- Availability of diagnostic AP and LAT X-ray or CT scan.
- Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
- Patient fulfills criteria for undergoing a surgical intervention.
- Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.
Who cannot join
- Open DRF or closed DRF with increased infection risk.
- Injury to the median nerve.
- Previous fracture of the target distal radius.
- Documented disease limiting mobility and functional assessments (eg. Grip strength test).
- Dependency on crutches or any comparable walking aids.
- Patient is overweight, has a BMI ≥35.
Show all 21Show fewer
- Presence of clinically significant infection at the target implant site or systemic infection.
- History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:
- Osteosynthesis materials (PEEK plate and screws).
- Anesthetic agents.
- Components of the NVDX3 implant.
- Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
- Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.
- Presence of an active tumor.
- 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.
- Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.
- Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.
- Any history of experimental therapy with another investigational drug within 60 days prior to screening.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- NVDX3
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVDX3Drug
NVDX3 is implanted during a single surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| NVDX3 implant | Experimental | Not described Receives: Drug: NVDX3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between the beginning of the implant surgery (IS) and 12 months post-IS
Secondary outcomes (55)
Safety: Serious TEAEs and NVDX3-related TEAEs
Number of participants with serious TEAEs and NVDX3-related TEAEs
Measured: 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
Measured: Beyond 6 weeks post-IS till 12 months post-IS
Safety: TEAEs
Number of participants with TEAEs
Measured: 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
Measured: Between the beginning of IS and 12 months post-IS
Safety: TEAEs of Special Interest
Number of participants with TEAEs of Special Interest
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 12 months post-IS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novadip Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Gerich, MD, Principal investigator, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987033
- Sponsor's protocol ID
- NVDX3-CLN01
- Other IDs
- 2023-508321-27-00, 2022-002304-21, 2023
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2023
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05987033
- Acronym / sponsor ID
- NVDX3-CLN01
- Conditions
- Distal Radius Fractures
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novadip BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVDX3 implant | Experimental | Drug: NVDX3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients within the age range of ≥18 years to ≤80 years.
- Patient diagnosed with DRF with confirmed:
- Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
- Patient fulfills criteria for undergoing a surgical intervention.
- Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.
Key exclusion criteria (21 listed)
- Open DRF or closed DRF with increased infection risk.
- Injury to the median nerve.
- Previous fracture of the target distal radius.
- Documented disease limiting mobility and functional assessments (eg. Grip strength test).
- Dependency on crutches or any comparable walking aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVDX3NVDX3 is implanted during a single surgical intervention. | Drug | NVDX3 implant |
Primary outcome
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs
Time frame: Between the beginning of the implant surgery (IS) and 12 months post-IS
Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs
55 secondary outcomes
Safety: Serious TEAEs and NVDX3-related TEAEs
Time frame: Between the beginning of IS and 6 weeks post-IS
Safety: Serious TEAEs and NVDX3-related TEAEs
Time frame: Beyond 6 weeks post-IS till 12 months post-IS
Safety: TEAEs
Time frame: 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
Time frame: Between the beginning of IS and 12 months post-IS
Safety: TEAEs of Special Interest
Time frame: Between the beginning of IS and 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Time frame: At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Time frame: At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Time frame: At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Time frame: At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Time frame: At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Time frame: At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Time frame: At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Time frame: At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Time frame: At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Time frame: At 12 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 2 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 6 weeks post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 3 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 6 months post-IS
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
Time frame: At 12 months post-IS
Efficacy: Clinical Assessments - Grip Strength
Time frame: At 2 weeks post-IS
Efficacy: Clinical Assessments - Grip Strength
Time frame: At 6 weeks post-IS
Efficacy: Clinical Assessments - Grip Strength
Time frame: At 3 months post-IS
Efficacy: Clinical Assessments - Grip Strength
Time frame: At 6 months post-IS
Efficacy: Clinical Assessments - Grip Strength
Time frame: At 12 months post-IS
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
Time frame: At Hospital Discharge
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
Time frame: At 2 weeks post-IS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Gerich, MD principal investigator
Centre Hospitalier du Luxembourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NVDX3 in people with Distal Radius Fractures, run by Novadip Biosciences at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs (time frame: Between the beginning of the implant surgery (IS) and 12 months post-IS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.