A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures
Phase 3
Withdrawn
- Conditions
- non-infected hypotrophic non-union fracturepseudoarthrosis10017322
- Registration Number
- NL-OMON41222
- Lead Sponsor
- Bone Therapeutics S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 34
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical symptoms: global disease evaluation using a visual analogue scale;<br /><br>radiological healing: Radiographic Union Scale for Tibial (RUST) Fracture<br /><br>extended to all long bones fractures as assessed by CT scan.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical symptoms:<br /><br>- Pain et fracture site at rest, during activities, at palpation using a Usual<br /><br>Analogue Scale<br /><br>-Well-being Score (SF12v2)<br /><br>- Weight-bearing score<br /><br><br /><br>Radiological healing: Radiographic Union Scale for Tibial (RUST) Fracture<br /><br>exiended to all long bones fractures as assessed by conventional X-ray.</p><br>