Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01529008|
Recruitment Status : Terminated (the interim results suggest that it is unlikely that the primary objective will be achieved at the final analysis)
First Posted : February 8, 2012
Results First Posted : June 24, 2022
Last Update Posted : June 24, 2022
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 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease.
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis of the Femoral Head||Drug: Core decompression/PREOB® implantation Drug: Core decompression/placebo implantation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 3, 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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 2018|
|Experimental: Core decompression/PREOB® implantation||
Drug: Core decompression/PREOB® implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|Placebo Comparator: Core decompression/placebo implantation||
Drug: Core decompression/placebo implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
- Percentage of Treatment Responders [ Time Frame: 24 months ]
A patient was considered as having responded to treatment if:
- the WOMAC VA3.1 pain subscale score (Western Ontario and McMaster Universitie Visual Analogue scale) of the study treated hip improved from baseline by at leat the MCID (minimal clinically important difference ) the WOMAC VA3.1 pain subscale score is Visual score based on 10 cm and
- the study treated hip did not progress to fractural stages (ARCO III or higher) as assessed by conventional X-ray