NL-OMON45063
Completed
Phase 3
Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head. - Efficacy and safety of autologous bone transplant for femoral head necrosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bone Therapeutics
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women, aged 18 to 70 years old, diagnosed with:
- •\- an ARCO stage I osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which is symptomatic (pain \* 20 mm on the WOMAC® VA3\.1 pain subscale during the 48 hours preceding the screening)
- •\- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which can be either symptomatic or asymptomatic
- •\- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles inferior to 190 degrees which is symptomatic (pain \* 20 mm on the WOMAC® VA3\.1 pain subscale during the 48 hours preceding)
Exclusion Criteria
- •ARCO stage III and IV osteonecrosis of the femoral head on the hip which is evaluated, and confirmed by conventional X\-ray and and MRI of the hip.
- •Osteoarthritis on the hip. Bone fracture that might interfere with study evaluation.
Outcomes
Primary Outcomes
Not specified
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