Distal Radius Fractures
Conditions
Brief summary
Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
Detailed description
This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin. As per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery.
Interventions
DRUGNVDX3
NVDX3 is implanted during a single surgical intervention.
Sponsors
Novadip Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients within the age range of ≥18 years to ≤80 years. 2. Patient diagnosed with DRF with confirmed: 1. Classification AO/ATO: C2 and C3 - Intra-articular \& multifragmentation. 2. Estimated volume of the targeted bone void should not exceed 5cc. 3. Availability of diagnostic AP and LAT X-ray or CT scan. 3. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis. 4. Patient fulfills criteria for undergoing a surgical intervention. 5. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.
Exclusion criteria
1. Open DRF or closed DRF with increased infection risk. 2. Injury to the median nerve. 3. Previous fracture of the target distal radius. 4. Documented disease limiting mobility and functional assessments (eg. Grip strength test). 5. Dependency on crutches or any comparable walking aids. 6. Patient is overweight, has a BMI ≥35. 7. Presence of clinically significant infection at the target implant site or systemic infection. 8. History of allergic reaction or any anticipated hypersensitivity to any of the anticipated: 1. Osteosynthesis materials (PEEK plate and screws). 2. Anesthetic agents. 3. Components of the NVDX3 implant. 9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders. 10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg. 11. Presence of an active tumor. 12. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism. 13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy. 14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening. 15. Any history of experimental therapy with another investigational drug within 60 days prior to screening. 16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study. 17. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results. 18. Patient with historically elevated radiation exposure levels that could in the opinion of the investigator have introduced unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs | Between the beginning of the implant surgery (IS) and 12 months post-IS | Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Serious TEAEs and NVDX3-related TEAEs | Between the beginning of IS and 6 weeks post-IS | Number of participants with serious TEAEs and NVDX3-related TEAEs |
| Safety: 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 | Number of participants with TEAEs |
| Safety: Related and Unexpected TEAEs and Serious TEAEs | Between the beginning of IS and 12 months post-IS | Number of participants with related and unexpected TEAEs and serious TEAEs |
| Safety: TEAEs of Special Interest | Between the beginning of IS and 12 months post-IS | Number of participants with TEAEs of Special Interest |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation | At 3 months post-IS | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union | At 3 months post-IS | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling | At 3 months post-IS | Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling |
| Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score | At 3 months post-IS | 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. |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation | At 2 weeks post-IS | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union | At 2 weeks post-IS | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling | At 2 weeks post-IS | Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling |
| Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score | At 2 weeks post-IS | 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. |
| Efficacy: Clinical Assessments - Grip Strength | At 2 weeks post-IS | Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side) |
| Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS) | At Hospital Discharge | 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. |
| Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE) | At 2 weeks post-IS | 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. |
| Efficacy: NRS-pain | At hospital discharge | 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). |
Countries
Luxembourg
Contacts
PRINCIPAL_INVESTIGATORTorsten Gerich, MD
Centre Hospitalier du Luxembourg
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 16.1 |
| Average daily number of cigarettes during the last 12 months | 9.0 number of cigarettes STANDARD_DEVIATION 11.3 |
| Childbearing Potential Status Childbearing potential | 2 Participants |
| Childbearing Potential Status Peri-menopausal (menopausal for less than 1 year) | 0 Participants |
| Childbearing Potential Status Postmenopausal for more than 1 year | 6 Participants |
| Childbearing Potential Status Surgical sterilisation | 0 Participants |
| Duration of tobacco use | 20.3 years STANDARD_DEVIATION 5.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Luxembourg | 10 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
| Use of Tobacco Current | 2 Participants |
| Use of Tobacco Former | 2 Participants |
| Use of Tobacco Never | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
None listed