Long Bone Non-Union
Conditions
Keywords
Non-Union Fractures, Impaired Healing, Fractures, Orthopedics, Bone, Musculoskeletal Disorders
Brief summary
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite. Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009). This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.
Interventions
DRUGPREOB® Implantation
PROCEDUREBone Autograft
Sponsors
Bone Therapeutics S.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements * Diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment * Normal hematology function
Exclusion criteria
* Positive serology for HIV, hepatitis B, hepatitis C, syphilis, HTLV-1 * Presence or previous history, or risk factors for diseases caused by prions * Renal impairment, hepatic impairment * Patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy * Insufficient fracture stability * Recent osteosynthesis material or bone graft * Multifocal fracture/non-unions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale | 12 months |
| Radiological healing progression using the RUS(T) as assessed by CT scan | 12 months |
| Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Pain using a Visual Analogue Scale | 12 months |
| Radiological improvement using the RUS(T) as assessed by X-ray | 12 months |
| Weight-bearing using Likert Scale | 12 months |
| Well-being score as assessed by the SF-12 questionnaire | 12 months |
Countries
Belgium, France, Netherlands
Outcome results
None listed