Trial Outcomes & Findings for Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures. (NCT NCT05987033)
NCT ID: NCT05987033
Last Updated: 2026-01-28
Results Overview
Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs
COMPLETED
PHASE1/PHASE2
11 participants
Between the beginning of the implant surgery (IS) and 12 months post-IS
2026-01-28
Participant Flow
Participant milestones
| Measure |
NVDX3 Implant
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Enrollment
STARTED
|
11
|
|
Enrollment
COMPLETED
|
10
|
|
Enrollment
NOT COMPLETED
|
1
|
|
Implantd with NVDX3
STARTED
|
10
|
|
Implantd with NVDX3
COMPLETED
|
9
|
|
Implantd with NVDX3
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
NVDX3 Implant
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Enrollment
Withdrawal by Subject
|
1
|
|
Implantd with NVDX3
Withdrawal by Subject
|
1
|
Baseline Characteristics
Current smokers
Baseline characteristics by cohort
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Use of Tobacco
Former
|
2 Participants
n=10 Participants
|
|
Average daily number of cigarettes during the last 12 months
|
9.0 number of cigarettes
STANDARD_DEVIATION 11.3 • n=2 Participants • Current smokers
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 16.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Luxembourg
|
10 Participants
n=10 Participants
|
|
Childbearing Potential Status
Childbearing potential
|
2 Participants
n=8 Participants • Women
|
|
Childbearing Potential Status
Surgical sterilisation
|
0 Participants
n=8 Participants • Women
|
|
Childbearing Potential Status
Peri-menopausal (menopausal for less than 1 year)
|
0 Participants
n=8 Participants • Women
|
|
Childbearing Potential Status
Postmenopausal for more than 1 year
|
6 Participants
n=8 Participants • Women
|
|
Use of Tobacco
Never
|
6 Participants
n=10 Participants
|
|
Use of Tobacco
Current
|
2 Participants
n=10 Participants
|
|
Duration of tobacco use
|
20.3 years
STANDARD_DEVIATION 5.3 • n=4 Participants • Former and current smokers
|
PRIMARY outcome
Timeframe: Between the beginning of the implant surgery (IS) and 12 months post-ISNumber of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs
Serious TEAE
|
1 Participants
|
|
Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs
NVDX3-related TEAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Between the beginning of IS and 6 weeks post-ISNumber of participants with serious TEAEs and NVDX3-related TEAEs
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: Serious TEAEs and NVDX3-related TEAEs
Serious TEAE
|
0 Participants
|
|
Safety: Serious TEAEs and NVDX3-related TEAEs
NVDX3-related TEAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Beyond 6 weeks post-IS till 12 months post-ISNumber of participants with serious TEAEs and NVDX3-related TEAEs
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: Serious TEAEs and NVDX3-related TEAEs
Serious TEAE
|
1 Participants
|
|
Safety: Serious TEAEs and NVDX3-related TEAEs
NVDX3-related TEAE
|
0 Participants
|
SECONDARY outcome
Timeframe: 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-ISNumber of participants with TEAEs
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: TEAEs
Between the beginning of IS and 6 weeks post-IS
|
7 Participants
|
|
Safety: TEAEs
Beyond 6 weeks post-IS till 12 months post-IS
|
8 Participants
|
|
Safety: TEAEs
Between the beginning of IS and 12 months post-IS
|
10 Participants
|
SECONDARY outcome
Timeframe: Between the beginning of IS and 12 months post-ISNumber of participants with related and unexpected TEAEs and serious TEAEs
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: Related and Unexpected TEAEs and Serious TEAEs
NVDX3-related TEAE
|
1 Participants
|
|
Safety: Related and Unexpected TEAEs and Serious TEAEs
NVDX3-related Serious TEAE
|
0 Participants
|
|
Safety: Related and Unexpected TEAEs and Serious TEAEs
Unexpected TEAE
|
10 Participants
|
|
Safety: Related and Unexpected TEAEs and Serious TEAEs
Unexpected Serious TEAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Between the beginning of IS and 12 months post-ISNumber of participants with TEAEs of Special Interest
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Safety: TEAEs of Special Interest
|
1 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
6 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
100% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
2 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation
Bone formation : 100% of the longitudinal gap filled
|
9 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
3 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
3 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
100% of the transverse gap filled
|
1 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union
100% of the transverse gap filled
|
8 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
1 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
6 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
0 Participants
|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
9 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score
|
8.2 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score
|
11.9 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
10 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
100% of the longitudinal gap filled
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
5 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
4 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
100% of the longitudinal gap filled
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
100% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
7 Participants
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
100% of the longitudinal gap filled
|
8 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray data using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 25% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 50% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 75% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Up to 100% of the longitudinal gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation
Bone formation : 100% of the longitudinal gap filled
|
9 Participants
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
10 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
100% of the transverse gap filled
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
2 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
6 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
2 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
100% of the transverse gap filled
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
5 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
3 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
100% of the transverse gap filled
|
1 Participants
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
5 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
100% of the transverse gap filled
|
4 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 25% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 50% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 75% of the transverse gap filled
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
Up to 100% of the transverse gap filled
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union
100% of the transverse gap filled
|
8 Participants
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
10 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
2 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
8 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
7 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
2 Participants
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
1 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
9 Participants
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
No evidence of remodelling against the baseline
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Possible remodelling of intramedullary canal
|
0 Participants
|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling
Full remodelling of the intramedullary canal and cortex
|
9 Participants
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
|
2.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
|
5.4 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
|
8.2 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
|
10.6 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score
|
11.9 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Grip Strength
Actual values
|
26.1 percentage
Standard Deviation 13.8
|
|
Efficacy: Clinical Assessments - Grip Strength
Change from baseline
|
25.0 percentage
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Grip Strength
Actual values
|
38.8 percentage
Standard Deviation 18.7
|
|
Efficacy: Clinical Assessments - Grip Strength
Change from baseline
|
38.7 percentage
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Grip Strength
Actual values
|
67.4 percentage
Standard Deviation 25.3
|
|
Efficacy: Clinical Assessments - Grip Strength
Change from baseline
|
67.1 percentage
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Grip Strength
Actual values
|
81.9 percentage
Standard Deviation 20.0
|
|
Efficacy: Clinical Assessments - Grip Strength
Change from baseline
|
82.0 percentage
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Grip Strength
Actual values
|
93.3 percentage
Standard Deviation 27.4
|
|
Efficacy: Clinical Assessments - Grip Strength
Change from baseline
|
93.3 percentage
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: At Hospital DischargePhysician 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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
36.7 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
45.0 score on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
44.5 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
69.0 score on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
76.5 score on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)
|
81.1 score on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Actual value
|
58.4 score on a scale
Standard Deviation 19.92
|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Change from baseline
|
-19.83 score on a scale
Standard Deviation 21.35
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Actual value
|
30.89 score on a scale
Standard Deviation 22.33
|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Change from baseline
|
-47.88 score on a scale
Standard Deviation 22.26
|
SECONDARY outcome
Timeframe: At 3 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Actual value
|
26.85 score on a scale
Standard Deviation 23.51
|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Change from baseline
|
-48.63 score on a scale
Standard Deviation 22.14
|
SECONDARY outcome
Timeframe: At 6 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Actual value
|
19.10 score on a scale
Standard Deviation 24.99
|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Change from baseline
|
-57.39 score on a scale
Standard Deviation 26.19
|
SECONDARY outcome
Timeframe: At 12 months post-ISPopulation: Number of patients with assessments
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.
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Actual value
|
13.44 score on a scale
Standard Deviation 19.13
|
|
Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)
Change from baseline
|
-63.31 score on a scale
Standard Deviation 19.06
|
SECONDARY outcome
Timeframe: At hospital dischargeNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Change from baseline
|
-1.5 score on a scale
Standard Deviation 3.1
|
|
Efficacy: NRS-pain
Actual value
|
3.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At 2 weeks post-ISNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Actual value
|
1.9 score on a scale
Standard Deviation 1.7
|
|
Efficacy: NRS-pain
Change from baseline
|
-2.6 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: At 6 weeks post-ISNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Actual value
|
1.7 score on a scale
Standard Deviation 1.8
|
|
Efficacy: NRS-pain
Change from baseline
|
-2.8 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: At 3 months post-ISNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Actual value
|
1.6 score on a scale
Standard Deviation 2.0
|
|
Efficacy: NRS-pain
Change from baseline
|
-2.9 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: At 6 months post-ISNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=10 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Actual value
|
1.2 score on a scale
Standard Deviation 2.4
|
|
Efficacy: NRS-pain
Change from baseline
|
-3.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: At 12 months post-ISNRS-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).
Outcome measures
| Measure |
NVDX3 Implant
n=9 Participants
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Efficacy: NRS-pain
Change from baseline
|
-3.1 score on a scale
Standard Deviation 3.0
|
|
Efficacy: NRS-pain
Actual value
|
1.2 score on a scale
Standard Deviation 2.0
|
Adverse Events
NVDX3 Implant
Serious adverse events
| Measure |
NVDX3 Implant
n=10 participants at risk
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
Other adverse events
| Measure |
NVDX3 Implant
n=10 participants at risk
NVDX3: NVDX3 is implanted during a single surgical intervention.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Investigations
Electrocardiogram abnormal
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Joint noise
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
General disorders
Peripheral swelling
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
30.0%
3/10 • Number of events 3 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Nervous system disorders
Paraesthesia
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Infections and infestations
Pulpitis dental
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Investigations
Platelet count increased
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Investigations
White blood cell count increased
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
General disorders
Pain
|
20.0%
2/10 • Number of events 2 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • From from the beginning of implant surgery (IS) till 12 months post-IS
Including abnormal safety laboratory results and abnormal vital signs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place