A Phase 2 interventional study of Core decompression/PREOB® implantation and Core decompression/BMC implantation in Avascular Necrosis of Femur Head, sponsored by Erasme University Hospital. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by Erasme University Hospital · Phase 2, Interventional, and Treatment
Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.
The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.
Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou \& Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.
This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. The primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.
184 studies on the registry are indexed under Osteonecrosis; 33 are open to participants now.
This study's enrollment of 82 is above the median of 51 across 98 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Core decompression/autologous osteoblastic cells (PREOB®) implantation
Drug: Core decompression/PREOB® implantation
Core decompression/bone marrow concentrate (BMC) implantation
Drug: Core decompression/BMC implantation
All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).
Percentage of responder subjects
Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement
Time frame: 24 months
Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
Time frame: 60 months
Percentage of responder subjects
Time frame: 3, 6, 12 and 36 months
Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray
Time frame: 3, 6, 12, 24 and 36 months
Change from baseline in VAS pain score
Time frame: 3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in WOMAC® score
Time frame: 3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in Lequesne score
Time frame: 3, 6, 12, 18, 24, 36 and 48 months
Proportion of subjects undergoing a total hip arthroplasty
Time frame: 6, 12, 24 and 36 months
Time to hip fracture
Time frame: 36 months
Plan to share: No
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital