Osteonecrosis Clinical Trial
Official title:
Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head
The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone matrix bound in autologous plasma after core decompression surgery is superior to core decompression with demineralized bone matrix bound in autologous plasma in preventing progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from the time of surgery until 24 months later, in patients with University of Pennsylvania (UPenn) Stage IIB or C disease at diagnosis.
This study is an event-driven, multi-center, prospective, independent observer-blinded,
controlled, randomized Phase III clinical trial enrolling patients diagnosed with University
of Pennsylvania (Steinberg) Classification Stage IIB or C osteonecrosis of the femoral head.
- The first patient group is the Treatment Group and will receive core decompression and
treatment with BRCs and demineralized bone matrix bound in autologous plasma, and
- The second patient group is the Control Group and will receive core decompression and
demineralized bone matrix bound in autologous plasma, without any BRCs.
- Enrollment: With an anticipated drop-out rate of 10% in up to twenty (20) sites, a total
of approximately 135 patients will be enrolled and randomized to obtain 120 evaluable
patients (75 for the TRC treatment group and 45 for the Control treatment group).
- Primary endpoint: The percentage of patients progressing to a more severe UPenn disease
stage (Stage II to III or higher) between 0 and 24 months will be the primary efficacy
variable to demonstrate TRC therapy is superior to Control therapy.
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