Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head (ON-CORE)
Other: Standard of Care Only
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head|
- The progression of patients with UPenn Stage IIB or IIC disease to a more severe stage based on all available x-ray and MRI imaging. Patients who have a definitive procedure but do not have a valid assessment will be considered to have progressed. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to progression (in months) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Osteonecrosis volume measured by MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Pain and quality of life questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
The Treatment arm of the study will receive study cellular product.
Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.
Active Comparator: Standard of Care Only
The Control arm of the study will receive standard of care therapy only.
Other: Standard of Care Only
Core decompression of the femoral head to remove necrotic tissue
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505219
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Minnesota|
|University of Minnesota Department of Orthopaedic Surgery|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Lutheran Medical Center|
|Brooklyn, New York, United States, 11220|
|Principal Investigator:||Marc Hungerford, MD||Johns Hopkins University|