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Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821470
Enrollment
21
Registered
2009-01-13
Start date
1999-01-31
Completion date
2008-09-30
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrosis

Keywords

osteonecrosis, bone marrow, core decompression, femoral head

Brief summary

Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. Core decompression of the hip is the most widespread procedure used to treat early stage ON of the femoral head. Notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with ON of the femoral head (9). The investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with ON of the femoral head (10). This finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.

Interventions

core decompression procedure only

PROCEDUREBone marrow implantation into the necrotic lesion

Sponsors

Fonds National de la Recherche Scientifique
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ARCO stage 1 or 2 osteonecrosis of the femoral head

Exclusion criteria

* The investigators excluded patients with evidence of a malignant disorder during the past five years.

Design outcomes

Primary

MeasureTime frame
WOMAC Score60 months

Secondary

MeasureTime frame
Disease progression defined as progression to a fractural stage of osteonecrosis60 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026