CompletedPhase 1/2

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

Luxembourg11 participantsStarted 2023-08-08

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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:
✓. 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:

What they're measuring

Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs

Timeframe: Between the beginning of the implant surgery (IS) and 12 months post-IS

Trial details

NCT IDNCT05987033

SponsorNovadip Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-19

Results submitted2026-01-12

View on ClinicalTrials.gov More Distal Radius Fractures trials