A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.

Conditions

• Congenital Pseudarthrosis of Tibia

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

• NVD003 — BIOLOGICAL
  Bone correction and grafting surgery
• Iliac Crest Bone Graft — PROCEDURE
  Either a single-stage Grafting Surgery with internal fixation and cross-union or the 2-stage "induced membrane" Grafting Surgery approach, depending on the surgeon's own standard of care.

Study Details

The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.

Key Dates

Start date

Sep 2, 2025

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm
  surgical grafting procedure: internal fixation with cross-union using NVD003
• Active Comparator: Standard of Care Arm
  Either a single-stage grafting surgery with internal fixation and cross-union or the 2-stage "induced membrane" grafting surgery approach, depending on the surgeon's own standard of Care.

Primary Outcome Measure

To assess the efficacy of NVD003 for the surgical treatment of CPT in pediatric participants [ Time Frame: At 12 months post GS ]

Central Contacts

• Judy Ashworth, MD
  224-713-6154
  [email protected]
• Lola TOME
  +447468479913
  [email protected]

Locations (4)

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