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Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

Primary Purpose

Distal Radius Fractures

Status
Recruiting
Phase
Phase 1
Locations
Luxembourg
Study Type
Interventional
Intervention
NVDX3
Sponsored by
Novadip Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients within the age range of ≥18 years to ≤80 years. Patient diagnosed with DRF with confirmed: Classification AO/ATO: C2 and C3 - Intra-articular & multifragmentation. Estimated volume of the targeted bone void should not exceed 5cc. Availability of diagnostic AP and LAT X-ray or CT scan. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis. Patient fulfills criteria for undergoing a surgical intervention. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent. 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: Osteosynthesis materials (PEEK plate and screws). Anesthetic agents. Components of the NVDX3 implant. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg. Presence of an active tumor. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening. Any history of experimental therapy with another investigational drug within 60 days prior to screening. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.

Sites / Locations

  • Centre Hospitalier de LuxembourgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NVDX3 implant

Arm Description

Outcomes

Primary Outcome Measures

Primary Endpoint: evaluation of SAEs and NVDX3 related AEs
Evaluation of all SAEs and NVDX3 related AEs

Secondary Outcome Measures

Safety: all acute SAEs and NVDX3 related AEs
Description of all acute SAEs and NVDX3 related AEs
Safety: all SAEs and NVDX3 related AEs
Description of all SAEs and NVDX3 related AEs
Safety: TEAEs
Description of Treatment Emergent AEs (TEAEs)
Safety: related and unexpected (S)AEs
Description of related and unexpected (S)AEs
Safety: AESI
Description of AE of Special Interest (AESI)
Safety: lab data
Description of lab data
Safety: vital signs
Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure
Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
Efficacy: Radiological assessments on X-ray using the eLSS tool
Radiological assessments on X-ray using the eLSS tool compared to the peri-operative x-ray acquisitions: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
Efficacy: Clinical assessments
Following clinical assessment will be performed compared to HD: Grip strength measure with a hydraulic hand dynamometer
Efficacy: Clinical assessments
Following clinical assessment will be performed compared to HD: Modified Mayo Wrist Score (MMWS): A physician-based scoring evaluating the patients' pain, active flexion/extension arc, grip strength and ability to return to regular employment or activities.
Efficacy: Clinical assessments
Following clinical assessment will be performed compared to HD: PRWE Questionnaire: A patient reported scoring evaluating the patients' wrist pain and disability
Efficacy: NRS-pain
NRS-pain, a patient reported scoring evaluating the patients' pain compared to Screening
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to NVDX3 density.
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of NVDX3.
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of surrounding tissue.
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to bone mineral density of native bone.

Full Information

First Posted
July 11, 2023
Last Updated
August 16, 2023
Sponsor
Novadip Biosciences
Collaborators
PrimeVigilance, Data Investigation Company Europe (DICE)
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1. Study Identification

Unique Protocol Identification Number
NCT05987033
Brief Title
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
Official Title
A First-in-human Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novadip Biosciences
Collaborators
PrimeVigilance, Data Investigation Company Europe (DICE)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NVDX3 implant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NVDX3
Intervention Description
NVDX3 is implanted during a single surgical intervention.
Primary Outcome Measure Information:
Title
Primary Endpoint: evaluation of SAEs and NVDX3 related AEs
Description
Evaluation of all SAEs and NVDX3 related AEs
Time Frame
Between screening (V1) and 12-months post- IS (V8)
Secondary Outcome Measure Information:
Title
Safety: all acute SAEs and NVDX3 related AEs
Description
Description of all acute SAEs and NVDX3 related AEs
Time Frame
Between screening (V1) and 6 weeks post-IS (V5)
Title
Safety: all SAEs and NVDX3 related AEs
Description
Description of all SAEs and NVDX3 related AEs
Time Frame
Beyond 6 weeks (V5 excluded) until 12 months post-IS
Title
Safety: TEAEs
Description
Description of Treatment Emergent AEs (TEAEs)
Time Frame
a. Between screening and week 6 (V5 included) b. Between week 6 (V5 excluded) till month 12 (V8 included) c. through study completion
Title
Safety: related and unexpected (S)AEs
Description
Description of related and unexpected (S)AEs
Time Frame
Between inclusion and 13 months post-IS
Title
Safety: AESI
Description
Description of AE of Special Interest (AESI)
Time Frame
Between inclusion and 13 months post-IS
Title
Safety: lab data
Description
Description of lab data
Time Frame
Between inclusion and 13 months post-IS
Title
Safety: vital signs
Description
Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure
Time Frame
Between inclusion and 13 months post-IS
Title
Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)
Description
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
Time Frame
At 3 and 12-months post-IS
Title
Efficacy: Radiological assessments on X-ray using the eLSS tool
Description
Radiological assessments on X-ray using the eLSS tool compared to the peri-operative x-ray acquisitions: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score
Time Frame
At HD, 2-, 6-weeks, 3-,6- and 12-months post-IS
Title
Efficacy: Clinical assessments
Description
Following clinical assessment will be performed compared to HD: Grip strength measure with a hydraulic hand dynamometer
Time Frame
At 2-,6 weeks, 3-, 6-, and 12-months post- IS
Title
Efficacy: Clinical assessments
Description
Following clinical assessment will be performed compared to HD: Modified Mayo Wrist Score (MMWS): A physician-based scoring evaluating the patients' pain, active flexion/extension arc, grip strength and ability to return to regular employment or activities.
Time Frame
At 2-,6 weeks, 3-, 6-, and 12-months post- IS
Title
Efficacy: Clinical assessments
Description
Following clinical assessment will be performed compared to HD: PRWE Questionnaire: A patient reported scoring evaluating the patients' wrist pain and disability
Time Frame
At 2-,6 weeks, 3-, 6-, and 12-months post- IS
Title
Efficacy: NRS-pain
Description
NRS-pain, a patient reported scoring evaluating the patients' pain compared to Screening
Time Frame
At HD, 2-,6 weeks, 3-, 6-, and 12-months post-IS
Title
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Description
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to NVDX3 density.
Time Frame
At 3-, and 12-months post-IS
Title
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Description
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of NVDX3.
Time Frame
At 3-, and 12-months post-IS
Title
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Description
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of surrounding tissue.
Time Frame
At 3-, and 12-months post-IS
Title
Exploratory: Radiological assessments on Dual Energy CT data (DECT)
Description
Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to bone mineral density of native bone.
Time Frame
At 3-, and 12-months post-IS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients within the age range of ≥18 years to ≤80 years. Patient diagnosed with DRF with confirmed: Classification AO/ATO: C2 and C3 - Intra-articular & multifragmentation. Estimated volume of the targeted bone void should not exceed 5cc. Availability of diagnostic AP and LAT X-ray or CT scan. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis. Patient fulfills criteria for undergoing a surgical intervention. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent. 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: Osteosynthesis materials (PEEK plate and screws). Anesthetic agents. Components of the NVDX3 implant. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg. Presence of an active tumor. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening. Any history of experimental therapy with another investigational drug within 60 days prior to screening. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Dufrane, MD
Phone
003210779220
Email
clinical@novadip.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dieter Frijns, MSc
Phone
003210779220
Email
clinical@novadip.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Gerich, MD
Organizational Affiliation
Centre Hospitalier du Luxembourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Luxembourg
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsten Gerich, MD
Email
gerich.torsten@chl.lu

12. IPD Sharing Statement

Learn more about this trial

Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

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