Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Non Traumatic Osteonecrosis of the Femoral Head (Hip) Clinical Trial

Official title:

Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544712
• Other study ID #: Ref 2004/08 st 3
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: March 5, 2012
• Start date: August 2004
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non Traumatic Osteonecrosis of the Femoral Head (Hip)
• Osteonecrosis

Intervention

Procedure:
• core decompression with autologous bone marrow implantation
core biopsy with injection of 40 ml concentrated autologous bone marrow.
• core decompression of the femoral head
core biopsy with injection of 40 ml saline solution in place of bone marrow.

Locations

Country	Name	City	State
Belgium	University of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of total prosthesis	Need to undergo a surgical treatment total prosthesis	24, 60 months	Yes
Secondary	Pain reduction	Visual analogue scale	24, 60 months	Yes
Secondary	functional status	Lequesne and WOMAC scores	24, 60 months	Yes