A Phase 1/2 interventional study of NVDX3 in Distal Radius Fractures, sponsored by Novadip Biosciences. Completed at 1 site in Luxembourg. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Novadip Biosciences · Phase 1/2, Interventional, and Treatment
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.
330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.
This study's enrollment of 11 is below the median of 62 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Novadip Biosciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient diagnosed with DRF with confirmed:
Exclusion Criteria:
History of allergic reaction or any anticipated to any of the anticipated:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: NVDX3
NVDX3 is implanted during a single surgical intervention.
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
Time frame: Between the beginning of the implant surgery (IS) and 12 months post-IS
Safety: Serious TEAEs and NVDX3-related TEAEs
Number of participants with 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
Number of participants with serious TEAEs and NVDX3-related TEAEs
Time frame: Beyond 6 weeks post-IS till 12 months post-IS
Safety: TEAEs
Number of participants with 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
Number of participants with related and unexpected TEAEs and serious TEAEs
Time frame: Between the beginning of IS and 12 months post-IS
Safety: TEAEs of Special Interest
Number of participants with 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
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At 12 months post-IS
| Milestone | NVDX3 Implant |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | NVDX3 Implant |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs
| Participants | NVDX3 Implant |
|---|---|
| Serious TEAE | 1 |
| NVDX3-related TEAE | 1 |
Number of participants with serious TEAEs and NVDX3-related TEAEs
| Participants | NVDX3 Implant |
|---|---|
| Serious TEAE | 0 |
| NVDX3-related TEAE | 1 |
Number of participants with serious TEAEs and NVDX3-related TEAEs
| Participants | NVDX3 Implant |
|---|---|
| Serious TEAE | 1 |
| NVDX3-related TEAE | 0 |
Number of participants with TEAEs
| Participants | NVDX3 Implant |
|---|---|
| Between the beginning of IS and 6 weeks post-IS | 7 |
| Beyond 6 weeks post-IS till 12 months post-IS | 8 |
| Between the beginning of IS and 12 months post-IS | 10 |
Number of participants with related and unexpected TEAEs and serious TEAEs
| Participants | NVDX3 Implant |
|---|---|
| NVDX3-related TEAE | 1 |
| NVDX3-related Serious TEAE | 0 |
| Unexpected TEAE | 10 |
| Unexpected Serious TEAE | 1 |
Number of participants with TEAEs of Special Interest
| Participants | NVDX3 Implant |
|---|---|
| Safety: TEAEs of Special Interest | 1 |
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 0 |
| Up to 75% of the longitudinal gap filled | 2 |
| Up to 100% of the longitudinal gap filled | 6 |
| 100% of the longitudinal gap filled | 1 |
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 0 |
| Up to 75% of the longitudinal gap filled | 0 |
| Up to 100% of the longitudinal gap filled | 0 |
| Bone formation : 100% of the longitudinal gap filled | 9 |
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 1 |
| Up to 50% of the transverse gap filled | 1 |
| Up to 75% of the transverse gap filled | 3 |
| Up to 100% of the transverse gap filled | 3 |
| 100% of the transverse gap filled | 1 |
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 0 |
| Up to 50% of the transverse gap filled | 0 |
| Up to 75% of the transverse gap filled | 0 |
| Up to 100% of the transverse gap filled | 1 |
| 100% of the transverse gap filled | 8 |
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 1 |
| Possible remodelling of intramedullary canal | 6 |
| Full remodelling of the intramedullary canal and cortex | 2 |
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.
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 0 |
| Possible remodelling of intramedullary canal | 0 |
| Full remodelling of the intramedullary canal and cortex | 9 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score | 8.2 ± 2.2 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score | 11.9 ± 0.3 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 10 |
| Up to 50% of the longitudinal gap filled | 0 |
| Up to 75% of the longitudinal gap filled | 0 |
| Up to 100% of the longitudinal gap filled | 0 |
| 100% of the longitudinal gap filled | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 5 |
| Up to 75% of the longitudinal gap filled | 4 |
| Up to 100% of the longitudinal gap filled | 1 |
| 100% of the longitudinal gap filled | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 1 |
| Up to 75% of the longitudinal gap filled | 1 |
| Up to 100% of the longitudinal gap filled | 7 |
| 100% of the longitudinal gap filled | 1 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 0 |
| Up to 75% of the longitudinal gap filled | 1 |
| Up to 100% of the longitudinal gap filled | 1 |
| 100% of the longitudinal gap filled | 8 |
Radiological assessments on X-ray data using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the longitudinal gap filled | 0 |
| Up to 50% of the longitudinal gap filled | 0 |
| Up to 75% of the longitudinal gap filled | 0 |
| Up to 100% of the longitudinal gap filled | 0 |
| Bone formation : 100% of the longitudinal gap filled | 9 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 10 |
| Up to 50% of the transverse gap filled | 0 |
| Up to 75% of the transverse gap filled | 0 |
| Up to 100% of the transverse gap filled | 0 |
| 100% of the transverse gap filled | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 2 |
| Up to 50% of the transverse gap filled | 6 |
| Up to 75% of the transverse gap filled | 2 |
| Up to 100% of the transverse gap filled | 0 |
| 100% of the transverse gap filled | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 1 |
| Up to 50% of the transverse gap filled | 0 |
| Up to 75% of the transverse gap filled | 5 |
| Up to 100% of the transverse gap filled | 3 |
| 100% of the transverse gap filled | 1 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 1 |
| Up to 50% of the transverse gap filled | 0 |
| Up to 75% of the transverse gap filled | 0 |
| Up to 100% of the transverse gap filled | 5 |
| 100% of the transverse gap filled | 4 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
| Participants | NVDX3 Implant |
|---|---|
| Up to 25% of the transverse gap filled | 0 |
| Up to 50% of the transverse gap filled | 0 |
| Up to 75% of the transverse gap filled | 0 |
| Up to 100% of the transverse gap filled | 1 |
| 100% of the transverse gap filled | 8 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 10 |
| Possible remodelling of intramedullary canal | 0 |
| Full remodelling of the intramedullary canal and cortex | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 2 |
| Possible remodelling of intramedullary canal | 8 |
| Full remodelling of the intramedullary canal and cortex | 0 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 1 |
| Possible remodelling of intramedullary canal | 7 |
| Full remodelling of the intramedullary canal and cortex | 2 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 1 |
| Possible remodelling of intramedullary canal | 0 |
| Full remodelling of the intramedullary canal and cortex | 9 |
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
| Participants | NVDX3 Implant |
|---|---|
| No evidence of remodelling against the baseline | 0 |
| Possible remodelling of intramedullary canal | 0 |
| Full remodelling of the intramedullary canal and cortex | 9 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | 2.0 ± 0.0 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | 5.4 ± 1.5 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | 8.2 ± 2.3 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | 10.6 ± 2.4 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | 11.9 ± 0.3 |
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
| percentage | NVDX3 Implant |
|---|---|
| Actual values | 26.1 ± 13.8 |
| Change from baseline | 25.0 ± 14.6 |
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
| percentage | NVDX3 Implant |
|---|---|
| Actual values | 38.8 ± 18.7 |
| Change from baseline | 38.7 ± 19.9 |
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
| percentage | NVDX3 Implant |
|---|---|
| Actual values | 67.4 ± 25.3 |
| Change from baseline | 67.1 ± 27.2 |
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
| percentage | NVDX3 Implant |
|---|---|
| Actual values | 81.9 ± 20.0 |
| Change from baseline | 82.0 ± 21.0 |
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
| percentage | NVDX3 Implant |
|---|---|
| Actual values | 93.3 ± 27.4 |
| Change from baseline | 93.3 ± 29.8 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 36.7 ± 8.3 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 45.0 ± 14.7 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 44.5 ± 15.9 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 69.0 ± 17.9 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 76.5 ± 22.0 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | 81.1 ± 22.2 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 58.4 ± 19.92 |
| Change from baseline | -19.83 ± 21.35 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 30.89 ± 22.33 |
| Change from baseline | -47.88 ± 22.26 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 26.85 ± 23.51 |
| Change from baseline | -48.63 ± 22.14 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 19.10 ± 24.99 |
| Change from baseline | -57.39 ± 26.19 |
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.
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 13.44 ± 19.13 |
| Change from baseline | -63.31 ± 19.06 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 3.0 ± 1.6 |
| Change from baseline | -1.5 ± 3.1 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 1.9 ± 1.7 |
| Change from baseline | -2.6 ± 3.1 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 1.7 ± 1.8 |
| Change from baseline | -2.8 ± 3.2 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 1.6 ± 2.0 |
| Change from baseline | -2.9 ± 3.7 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 1.2 ± 2.4 |
| Change from baseline | -3.3 ± 2.2 |
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).
| score on a scale | NVDX3 Implant |
|---|---|
| Actual value | 1.2 ± 2.0 |
| Change from baseline | -3.1 ± 3.0 |
Collected over From from the beginning of implant surgery (IS) till 12 months post-IS. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NVDX3 Implant | 0/10 (0%) | 1/10 (10%) | 10/10 (100%) |
| Event | NVDX3 Implant |
|---|---|
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/10 |
| Event | NVDX3 Implant |
|---|---|
| Joint swellingMusculoskeletal and connective tissue disorders | 3/10 |
| Procedural painInjury, poisoning and procedural complications | 2/10 |
| Peripheral swellingGeneral disorders | 2/10 |
| ParaesthesiaNervous system disorders | 2/10 |
| FatigueGeneral disorders | 2/10 |
| PainGeneral disorders | 2/10 |
| NauseaGastrointestinal disorders | 2/10 |
| Electrocardiogram abnormalInvestigations | 2/10 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 1/10 |
| Fracture painMusculoskeletal and connective tissue disorders | 1/10 |
| Age, Continuous(years) | NVDX3 Implant |
|---|---|
| Mean | 61.6 ± 16.1 |
| Sex: Female, Male(Participants) | NVDX3 Implant |
|---|---|
| Female | 8 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | NVDX3 Implant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | NVDX3 Implant |
|---|---|
| Luxembourg | 10 |
| Childbearing Potential Status(Participants) | NVDX3 Implant |
|---|---|
| Childbearing potential | 2 |
| Surgical sterilisation | 0 |
| Peri-menopausal (menopausal for less than 1 year) | 0 |
| Postmenopausal for more than 1 year | 6 |
| Use of Tobacco(Participants) | NVDX3 Implant |
|---|---|
| Never | 6 |
| Current | 2 |
| Former | 2 |
| Average daily number of cigarettes during the last 12 months(number of cigarettes) | NVDX3 Implant |
|---|---|
| Mean | 9.0 ± 11.3 |
| Duration of tobacco use(years) | NVDX3 Implant |
|---|---|
| Mean | 20.3 ± 5.3 |
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