non infected hypotrophic non union fracture - pseudoarthrosis
Conditions
Interventions
Study part 1:
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 frac
Sponsors
Bone Therapeutics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: men and women aged between 18 and 65 diagnosed with non-infected hypotrophic non union fractures as confirmed by X-ray
Exclusion criteria
Exclusion criteria: Fracture interline > 1cm Open fracture with septic local infection Insufficient fracture stability osteosynthesis material other than intramedullary nails or plates bone infection open fracture 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 Visual Analogue Scale - Well-being Score (SF12v2) - Weight-bearing score Radiological healing: Radiographic Union Scale for Tibial (RUST) Fracture extended to all long bones fractures as assessed by conventional X-ray. Tme to bone autograft rescue surgery if applicable (part 1 study only). | — |
Countries
Netherlands
Outcome results
None listed