Status:
COMPLETED
A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union
Lead Sponsor:
Universidad Autonoma de Madrid
Conditions:
Non Union Fracture
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long...
Detailed Description
Bone injuries represent an important world medical problem producing significant healthcare and societal expenditure. While most bone injuries are not severe and are capable of healing through bone re...
Eligibility Criteria
Inclusion
- Age 18 years and older, both sexes
- Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union.
- Able to understand, accept and sign informed consent
- Medical health coverage
- Able to understand and accept the study constraints
Exclusion
- Hypertrophic non-unions
- Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
- Unrecovered vascular or neural injury
- Other fractures causing interference with weight bearing
- Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
- Active infection of any location and aetiology
- Surgical contraindication of any cause
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
- Malignant tumour (past history or concurrent disease)(except carcinoma in situ or basalioma in remission)
- History of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection
- Insulin dependent diabetes
- Any evidence (confirmed by PCR) of active infection with HIV, Hepatitis B or Hepatitis C infection
- Any evidence of Syphilis
- Known allergies to products involved in the production process of MSC
- Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion
- Autoimmune inflammatory disease
- Current treatment by biphosphonates not stopped three months prior to study inclusion
- Impossibility to meet at the appointments for the follow up
- Participation in another therapeutic trial in the previous 3 months
- Second non-union in case of bilateral or multiple non-unions (only one non-union per patient will be included in the trial)
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03325504
Start Date
September 5 2017
End Date
December 15 2023
Last Update
December 4 2024
Active Locations (19)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France
2
Department of Orthopaedic Surgery, Hospital Henri Mondor
Créteil, France
3
Department of Orthopaedic Surgery, CHU Nantes
Nantes, France
4
Department of Orthopaedic Surgery Toulouse University Hospital
Toulouse, France