Delayed Union After Fracture of Humerus, Tibial or Femur Clinical Trial
— OrthoCT1Official title:
Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics
| Verified date | November 2017 |
| Source | Institut National de la Santé Et de la Recherche Médicale, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal
tissue. In Europe, about one million patients encounter a surgical bone reconstruction
annually and the numbers are increasing due to our ageing population. Bone grafting intends
to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage,
but this is only attained presently by including cells capable of forming bone into the
augmentation.
Bone autograft is the safest and most effective grafting procedure, since it contains
patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance
osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction).
However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from
the iliac crest) represents an additional surgical intervention, with frequent consequent
pain and complications.
We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically
implanted with synthetic bone substitutes contribute to the resolution of the health and
socioeconomic complications of delayed union or non-union after diaphyseal and
metaphyseal-diaphyseal fractures with safety and efficacy.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 5, 2016 |
| Est. primary completion date | February 5, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Age 18 to 65, both sexes - Traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphyseal-diaphyseal fracture status delayed union or non-union - At least 3 months from acute fracture - Able to provide informed consent, and signed informed consent - Patients (by themselves) should have medical health care coverage to be included in a research study - Able to understand and accept the study constraints Exclusion Criteria: - Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control - Participation in another therapeutic trial in the previous 3 months - Delayed union or non-union related to iatrogeny - Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc) - Vascular or neural injury - Other fractures causing interference with weight bearing - Acute persistent chronic bacterial infections such as brucellosis, typhus, leprosy, relapsing fever, melioidosis and tularemia - Visceral injuries of diseases interfering with callus formation (cranioencephalic trauma, etc.) - History of bone harvesting on iliac crest contraindicating bone-marrow aspiration - Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion - History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR) - History of neoplasia or current neoplasia in any organ - Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility. - Impossibility to meet at the appointments for the follow up - Insulin dependent diabetes - Obesity (BMI > 30) - Autoimmune inflammatory disease - Current treatment by biphosphonate or stopped in the three months prior to study inclusion. |
| Country | Name | City | State |
|---|---|---|---|
| France | Depatment of Orthopaedic Surgery, Hôpital Henri Mondor | Créteil | |
| France | Department of Orthopaedic Surgery, CHRU Tours | Tours | |
| Germany | Department of Orthopaedic Trauma, University of Ulm | Ulm | |
| Italy | Istituto Ortopedico Rizzoli, Bologna | Bologna | |
| Spain | Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France |
France, Germany, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complication rate as percentage of patients with local complications regarding the non-union treatment in the follow-up | At 6 weeks, 12 weeks, 24 weeks and 52 weeks after the implantation surgery | ||
| Secondary | Number of patients with proven bone healing | 6 weeks, 12 weeks, and 24 weeks after the implantation surgery | ||
| Secondary | Amount of radiological callus | 6 weeks, 12 weeks, and 24 weeks after the implantation surgery | ||
| Secondary | Clinical consolidation | 6 weeks, 12 weeks, and 24 weeks after implantation surgery | ||
| Secondary | No reoperation done or scheduled | 24 weeks after implantation surgery | ||
| Secondary | Changes in serum levels of bone turnover markers | 6 weeks, 12 weeks, and 24 weeks after the implantation surgery |