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Withdrawn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 fracture - pseudoarthrosis
10017322

Registration Number: NL-OMON37100

Lead Sponsor: Bone Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 49

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

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

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><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 Visual<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>extended to all long bones fractures as assessed by conventional X-ray.<br /><br><br /><br>Tme to bone autograft rescue surgery if applicable (part 1 study only).</p><br>