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

NCT05987033 | Completed Phase 1 Results

• 3 other identifiers: NVDX3-CLN012023-508321-27-002022-002304-21
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (55)

• Safety: Serious TEAEs and NVDX3-related TEAEs

  Between the beginning of IS and 6 weeks post-IS

• Safety: Serious TEAEs and NVDX3-related TEAEs

  Beyond 6 weeks post-IS till 12 months post-IS

• 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

• Safety: Related and Unexpected TEAEs and Serious TEAEs

  Between the beginning of IS and 12 months post-IS

• Safety: TEAEs of Special Interest

  Between the beginning of IS and 12 months post-IS

Study Arms (1)

NVDX3 implant

EXPERIMENTAL

Drug: NVDX3

Interventions

NVDX3 DRUG

NVDX3 is implanted during a single surgical intervention.

NVDX3 implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novadip Biosciences: lead

Study Sites (1)

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Novadip Biosciences

clinical@novadip.com

+32(0)10 77 92 20

Study Officials

• Torsten Gerich, MD

  Centre Hospitalier du Luxembourg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 14, 2023
• Study Start: August 8, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Locations

LU (1)