Non Traumatic Osteonecrosis of the Femoral Head (Hip)NCT01544712
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
A study testing core decompression with autologous bone marrow implantation and core decompression of the femoral head in people with Non Traumatic Osteonecrosis of the Femoral Head (Hip), run by University of Liege at 1 site in Belgium.
Trial summary
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Traumatic Osteonecrosis of the Femoral Head (Hip)
- What is being tested?
- core decompression with autologous bone marrow implantation and core decompression of the femoral head
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2004to Sep 2010
- Phase
- Interventional
- 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
- patients who have a non traumatic ON of the femoral head
- Stage 3 ON (subchondral fracture).
- Age > 18 years
- Be able and willing to participate in the study
Who cannot join
- evidence of malignant disorder in the past five years
- Patient unable to undergo a MRI.
- Patient who is positive for an HIV, hepatitis B or C infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.
- Being tested
- core decompression with autologous bone marrow implantation, core decompression of the femoral head
- Keywords
- osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core decompression with autologous bone marrow implantationProcedure or surgery
core biopsy with injection of 40 ml concentrated autologous bone marrow.
core decompression of the femoral headProcedure or surgery
core biopsy with injection of 40 ml saline solution in place of bone marrow.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Core decompression Receives: Procedure: core decompression of the femoral head |
| Bone marrow | Experimental | core decompression plus autologous concentrated bone marrow Receives: Procedure: core decompression with autologous bone marrow implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of total prosthesis
Need to undergo a surgical treatment total prosthesis
Measured: 24, 60 months
Secondary outcomes (2)
Pain reduction
Visual analogue scale
Measured: 24, 60 months
functional status
Lequesne and WOMAC scores
Measured: 24, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startAug 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Traumatic Osteonecrosis of the Femoral Head (Hip)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Philippe Hauzeur, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544712
- Sponsor's protocol ID
- Ref 2004/08 st 3
- Status last verified
- Feb 2012
- First submitted
- 22 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018 Jul;42(7):1429-1435. doi: 10.1007/s00264-017-3650-8. Epub 2017 Oct 7.
PubMed 28988340
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT01544712
- Acronym / sponsor ID
- Ref 2004/08 st 3
- Keywords
- osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Mar 2012 (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.
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: core decompression of the femoral headCore decompression |
| Bone marrow | Experimental | Procedure: core decompression with autologous bone marrow implantationcore decompression plus autologous concentrated bone marrow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who have a non traumatic ON of the femoral head
- Stage 3 ON (subchondral fracture).
- Age > 18 years
- Be able and willing to participate in the study
Key exclusion criteria (3 listed)
- evidence of malignant disorder in the past five years
- Patient unable to undergo a MRI.
- Patient who is positive for an HIV, hepatitis B or C infection.
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 with autologous bone marrow implantationcore biopsy with injection of 40 ml concentrated autologous bone marrow. | Procedure or surgery | Bone marrow |
| core decompression of the femoral headcore biopsy with injection of 40 ml saline solution in place of bone marrow. | Procedure or surgery | Control |
Primary outcome
reduction of total prosthesis
Time frame: 24, 60 months
Need to undergo a surgical treatment total prosthesis
2 secondary outcomes
Pain reduction
Time frame: 24, 60 months
functional status
Time frame: 24, 60 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 6 Mar 2012.
- Derived from this study: PubMed 28988340Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018 Jul;42(7):1429-1435. doi: 10.1007/s00264-017-3650-8. Epub 2017 Oct 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core decompression with autologous bone marrow implantation and core decompression of the femoral head in people with Non Traumatic Osteonecrosis of the Femoral Head (Hip), run by University of Liege at 1 site 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 4 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
reduction of total prosthesis (time frame: 24, 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544712, which also lists 1 linked publication.
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 6 Mar 2012.