Avascular Necrosis of Femur HeadPhase 2PREOB-ON2NCT02890537
Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
A Phase 2 study testing Core decompression/PREOB® implantation and Core decompression/BMC implantation in people with Avascular Necrosis of Femur Head, run by Erasme University Hospital at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis of Femur Head
- What is being tested?
- Core decompression/PREOB® implantation and Core decompression/BMC implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2003to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
- Aged 18 or higher
- Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements
Who cannot join
- Evidence of malignant disorder in the past five years
- Positive serology for hepatitis B, hepatitis C, HIV
- Patient unable to undergo a MRI
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
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.
Read more
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.
- Conditions
- Avascular Necrosis of Femur Head
- Being tested
- Core decompression/PREOB® implantation, Core decompression/BMC implantation
- Keywords
- Osteonecrosis, Femoral Head, Hip, Orthopedics, Bone, Musculoskeletal Disorders
- Medical subject headings
- Femur Head Necrosis, Osteonecrosis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core decompression/PREOB® implantationDrug
All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
Core decompression/BMC implantationDrug
All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).
| Study group | Role | What they receive |
|---|---|---|
| Core decompression/PREOB® implantation | Experimental | Core decompression/autologous osteoblastic cells (PREOB®) implantation Receives: Drug: Core decompression/PREOB® implantation |
| Core decompression/BMC implantation | Active comparator | Core decompression/bone marrow concentrate (BMC) implantation Receives: Drug: Core decompression/BMC implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responder subjects
Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement
Measured: 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
Measured: 60 months
Secondary outcomes (7)
Percentage of responder subjects
Measured: 3, 6, 12 and 36 months
Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray
Measured: 3, 6, 12, 24 and 36 months
Change from baseline in VAS pain score
Measured: 3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in WOMAC® score
Measured: 3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in Lequesne score
Measured: 3, 6, 12, 18, 24, 36 and 48 months
Proportion of subjects undergoing a total hip arthroplasty
Measured: 6, 12, 24 and 36 months
Time to hip fracture
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startOct 2003
- Primary completionMay 2011
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of Femur HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, Bone Therapeutics S.A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890537
- Sponsor's protocol ID
- 2003/281
- Acronym
- PREOB-ON2
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
- ClinicalTrials.gov ID
- NCT02890537
- Acronym / sponsor ID
- PREOB-ON2 / 2003/281
- Conditions
- Avascular Necrosis of Femur Head
- Keywords
- Osteonecrosis, Femoral Head, Hip, Orthopedics, Bone, Musculoskeletal Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University of Liege, Bone Therapeutics S.A
- Study start
- Oct 2003
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core decompression/PREOB® implantation | Experimental | Drug: Core decompression/PREOB® implantationCore decompression/autologous osteoblastic cells (PREOB®) implantation |
| Core decompression/BMC implantation | Active comparator | Drug: Core decompression/BMC implantationCore decompression/bone marrow concentrate (BMC) implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
- Aged 18 or higher
- Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements
Key exclusion criteria (3 listed)
- Evidence of malignant disorder in the past five years
- Positive serology for hepatitis B, hepatitis C, HIV
- Patient unable to undergo a MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core decompression/PREOB® implantationAll subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration). | Drug | Core decompression/PREOB® implantation |
| Core decompression/BMC implantationAll subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration). | Drug | Core decompression/BMC implantation |
Primary outcome
Percentage of responder subjects
Time frame: 24 months
Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Core decompression/PREOB® implantation and Core decompression/BMC implantation in people with Avascular Necrosis of Femur Head, run by Erasme University Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responder subjects (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.