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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508321-27-00 | EU Trial (CTIS) Number | ||
| 2022-002304-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVDX3 implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVDX3 | Drug | NVDX3 is implanted during a single surgical intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs | Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs | Between the beginning of the implant surgery (IS) and 12 months post-IS |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Serious TEAEs and NVDX3-related TEAEs | Number of participants with serious TEAEs and NVDX3-related TEAEs | Between the beginning of IS and 6 weeks post-IS |
| Safety: Serious TEAEs and NVDX3-related TEAEs |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Torsten Gerich, MD | Centre Hospitalier du Luxembourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Luxembourg | Luxembourg | 1210 | Luxembourg |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVDX3 Implant | NVDX3: NVDX3 is implanted during a single surgical intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| ||||||||||||||||||
| Implantd with NVDX3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | NVDX3 Implant | NVDX3: NVDX3 is implanted during a single surgical intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Between the beginning of the implant surgery (IS) and 12 months post-IS |
|
|
From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NVDX3 Implant | NVDX3: NVDX3 is implanted during a single surgical intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Novadip Biosciences | +32(0)10 77 92 20 | clinical@novadip.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2023 | Jan 12, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2024 | Jan 12, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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Number of participants with serious TEAEs and NVDX3-related TEAEs
| Beyond 6 weeks post-IS till 12 months post-IS |
| Safety: TEAEs | Number of participants with TEAEs | Between the beginning of IS and 6 weeks post-IS Beyond 6 weeks post-IS till 12 months post-IS Between the beginning of IS and 12 months post-IS |
| Safety: Related and Unexpected TEAEs and Serious TEAEs | Number of participants with related and unexpected TEAEs and serious TEAEs | Between the beginning of IS and 12 months post-IS |
| Safety: TEAEs of Special Interest | Number of participants with TEAEs of Special Interest | Between the beginning of IS and 12 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 3 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 12 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 3 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 12 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 3 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing. | At 12 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing. | At 3 months post-IS |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing. | At 12 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 2 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 6 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 3 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 6 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | Radiological assessments on X-ray data using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation | At 12 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 2 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 6 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 3 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 6 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union | At 12 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 2 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 6 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 3 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 6 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling | At 12 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing. | At 2 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing. | At 6 weeks post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing. | At 3 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing. | At 6 months post-IS |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing. | At 12 months post-IS |
| Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | At 2 weeks post-IS |
| Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | At 6 weeks post-IS |
| Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | At 3 months post-IS |
| Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | At 6 months post-IS |
| Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | At 12 months post-IS |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At Hospital Discharge |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At 2 weeks post-IS |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At 6 weeks post-IS |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At 3 months post-IS |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At 6 months post-IS |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result. | At 12 months post-IS |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability. | At 2 weeks post-IS |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability. | At 6 weeks post-IS |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability. | At 3 months post-IS |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability. | At 6 months post-IS |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | PRWE total score The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability. | At 12 months post-IS |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At hospital discharge |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At 2 weeks post-IS |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At 6 weeks post-IS |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At 3 months post-IS |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At 6 months post-IS |
| Efficacy: NRS-pain | NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable). | At 12 months post-IS |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Childbearing Potential Status | Women | Count of Participants | Participants |
|
| Use of Tobacco | Count of Participants | Participants |
|
| Average daily number of cigarettes during the last 12 months | Current smokers | Mean | Standard Deviation | number of cigarettes |
|
| Duration of tobacco use | Former and current smokers | Mean | Standard Deviation | years |
|
|
| Secondary | Safety: Serious TEAEs and NVDX3-related TEAEs | Number of participants with serious TEAEs and NVDX3-related TEAEs | Posted | Count of Participants | Participants | Between the beginning of IS and 6 weeks post-IS |
|
|
|
| Secondary | Safety: Serious TEAEs and NVDX3-related TEAEs | Number of participants with serious TEAEs and NVDX3-related TEAEs | Posted | Count of Participants | Participants | Beyond 6 weeks post-IS till 12 months post-IS |
|
|
|
| Secondary | Safety: TEAEs | Number of participants with TEAEs | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Safety: Related and Unexpected TEAEs and Serious TEAEs | Number of participants with related and unexpected TEAEs and serious TEAEs | Posted | Count of Participants | Participants | Between the beginning of IS and 12 months post-IS |
|
|
|
| Secondary | Safety: TEAEs of Special Interest | Number of participants with TEAEs of Special Interest | Posted | Count of Participants | Participants | Between the beginning of IS and 12 months post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
|
|
|
| Secondary | 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. | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 12 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 2 weeks post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 weeks post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 2 weeks post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 weeks post-IS |
|
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|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 2 weeks post-IS |
|
|
|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 weeks post-IS |
|
|
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 3 months post-IS |
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| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 6 months post-IS |
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|
| Secondary | 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 | Number of patients with assessments | Posted | Count of Participants | Participants | At 12 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 2 weeks post-IS |
|
|
|
| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 weeks post-IS |
|
|
|
| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-IS |
|
|
|
| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 months post-IS |
|
|
|
| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 12 months post-IS |
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| Secondary | Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | Number of patients with assessments | Posted | Mean | Standard Deviation | percentage | At 2 weeks post-IS |
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| Secondary | Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | Number of patients with assessments | Posted | Mean | Standard Deviation | percentage | At 6 weeks post-IS |
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| Secondary | Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | Number of patients with assessments | Posted | Mean | Standard Deviation | percentage | At 3 months post-IS |
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|
| Secondary | Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | Number of patients with assessments | Posted | Mean | Standard Deviation | percentage | At 6 months post-IS |
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|
| Secondary | Efficacy: Clinical Assessments - Grip Strength | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) | Number of patients with assessments | Posted | Mean | Standard Deviation | percentage | At 12 months post-IS |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At Hospital Discharge |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 2 weeks post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 weeks post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 12 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 2 weeks post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 weeks post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-IS |
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|
| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 6 months post-IS |
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| Secondary | 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. | Number of patients with assessments | Posted | Mean | Standard Deviation | score on a scale | At 12 months post-IS |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At hospital discharge |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At 2 weeks post-IS |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At 6 weeks post-IS |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-IS |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At 6 months post-IS |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | At 12 months post-IS |
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|
| 0 |
| 10 |
| 1 |
| 10 |
| 10 |
| 10 |
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Pulpitis dental | Infections and infestations | Systematic Assessment |
|
| Platelet count increased | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Scar pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Joint noise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching scar | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
|
| Unexpected Serious TEAE |
|
| Title | Measurements |
|---|---|
|
| Up to 100% of the longitudinal gap filled |
|
| 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|---|
|
| Up to 100% of the longitudinal gap filled |
|
| Bone formation : 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|
|
| Up to 100% of the longitudinal gap filled |
|
| 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the longitudinal gap filled |
|
| 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the longitudinal gap filled |
|
| 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the longitudinal gap filled |
|
| 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the longitudinal gap filled |
|
| Bone formation : 100% of the longitudinal gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the transverse gap filled |
|
| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|
|
| Up to 100% of the transverse gap filled |
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| 100% of the transverse gap filled |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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