non-infected hypotrophic non-union fracture pseudoarthrosis
Conditions
Interventions
Study group: percutaneous injection of 2,3, or 4 ml PREOB® suspension
(depending on the fracture interline, at a concentration of 4 x 10E6 cells/ml)
using a 3 mm trephine into the fracture site.
Co
Sponsors
Bone Therapeutics S.A.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men and women, aged between 18 and 65 years old Diagnosed with non-infected hypotrophic non-union fractures as confirmed by X-ray
Exclusion criteria
Exclusion criteria: Fracture interline > 1 cm Open fracture with septic local infection Insufficient fracture stability Osteosynthesis material other than intramedullary nails, scews, plates or external fixation Bone infection Multifocal fracture / non-union Non-union or non-consolidated fracture on the neighbouring bone Nerve damages or tendon lesion at the non-union fracture site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms: global disease evaluation using a visual analogue scale; radiological healing: Radiographic Union Scale for Tibial (RUST) Fracture extended to all long bones fractures as assessed by CT scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms: - Pain et fracture site at rest, during activities, at palpation using a Usual Analogue Scale -Well-being Score (SF12v2) - Weight-bearing score Radiological healing: Radiographic Union Scale for Tibial (RUST) Fracture exiended to all long bones fractures as assessed by conventional X-ray. | — |
Countries
Netherlands
Outcome results
None listed