Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedMarch 6, 2012
February 1, 2012
6.1 years
February 22, 2012
March 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of total prosthesis
Need to undergo a surgical treatment total prosthesis
24, 60 months
Secondary Outcomes (2)
Pain reduction
24, 60 months
functional status
24, 60 months
Study Arms (2)
Control
ACTIVE COMPARATORCore decompression
Bone marrow
EXPERIMENTALcore decompression plus autologous concentrated bone marrow
Interventions
core biopsy with injection of 40 ml concentrated autologous bone marrow.
core biopsy with injection of 40 ml saline solution in place of bone marrow.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Liège
Liège, Liège, 4000, Belgium
Related Publications (1)
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.
PMID: 28988340DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 6, 2012
Study Start
August 1, 2004
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 6, 2012
Record last verified: 2012-02