Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05693558
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with congenital pseudarthrosis of the tibia (with or without NF1) and presenting with a non-healing Paley type 3 or 4 fracture.
* Minimum weight of 5kg/11lbs.
* Maximum 2 previous failed surgical orthopaedic interventions to treat the primary CPT fracture.
* Acceptable serology and molecular test results excluding the presence of viruses
* Satisfactory general health condition to undergo surgeries (ATC and GS) with anaesthesia as per local standards.
* The patient's parent(s) and/or legal guardian(s) provided written informed consent and accepted the participation of the patient in the trial.
Exclusion Criteria:
* Bilateral CPT.
* Presence of CPT without a fracture of the tibia (Paley type 1 and 2).
* More than 2 failed surgical attempt(s) to treat the primary tibial fracture.
* Evidence of plexiform neurofibroma of any size or nodular fibroma ≥ 1.2in/3cm on the ipsilateral leg.
* Clinically significant infection at the target grafting site or systemic infection.
* Presence of clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., CBC, PT/INR, Chem-7, and LFTs, etc.).
* Presence of any auto-immune disease, with exception of well controlled diabetes type 1 or auto-immune thyroid disorders.
* Any history of experimental therapy with another investigational drug within 60 days prior to screening.
* Presence of active tumour.
* Documented metabolic bone disease or any disorder, such as but not limited to osteogenesis imperfecta and osteomalacia, 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, anticoagulant therapies, immunosuppressant therapy or immunotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
8 Years
Study:
NCT05693558
Study Brief:
Protocol Section:
NCT05693558