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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
NVDX3 is implanted during a single surgical intervention.
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
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
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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