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Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Primary Purpose

Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
core decompression with autologous bone marrow implantation
core decompression of the femoral head
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Traumatic Osteonecrosis of the Femoral Head (Hip) focused on measuring osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients who have a non traumatic ON of the femoral head
  2. Stage 3 ON (subchondral fracture).
  3. Age > 18 years
  4. Be able and willing to participate in the study

Exclusion Criteria:

  1. evidence of malignant disorder in the past five years
  2. Patient unable to undergo a MRI.
  3. Patient who is positive for an HIV, hepatitis B or C infection.

Sites / Locations

  • University of Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Bone marrow

Arm Description

Core decompression

core decompression plus autologous concentrated bone marrow

Outcomes

Primary Outcome Measures

reduction of total prosthesis
Need to undergo a surgical treatment total prosthesis

Secondary Outcome Measures

Pain reduction
Visual analogue scale
functional status
Lequesne and WOMAC scores

Full Information

First Posted
February 22, 2012
Last Updated
March 5, 2012
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT01544712
Brief Title
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
Official Title
Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Traumatic Osteonecrosis of the Femoral Head (Hip)
Keywords
osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Core decompression
Arm Title
Bone marrow
Arm Type
Experimental
Arm Description
core decompression plus autologous concentrated bone marrow
Intervention Type
Procedure
Intervention Name(s)
core decompression with autologous bone marrow implantation
Intervention Description
core biopsy with injection of 40 ml concentrated autologous bone marrow.
Intervention Type
Procedure
Intervention Name(s)
core decompression of the femoral head
Intervention Description
core biopsy with injection of 40 ml saline solution in place of bone marrow.
Primary Outcome Measure Information:
Title
reduction of total prosthesis
Description
Need to undergo a surgical treatment total prosthesis
Time Frame
24, 60 months
Secondary Outcome Measure Information:
Title
Pain reduction
Description
Visual analogue scale
Time Frame
24, 60 months
Title
functional status
Description
Lequesne and WOMAC scores
Time Frame
24, 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
28988340
Citation
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.
Results Reference
derived

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Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

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