Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

University of Liege

Status: Completed

Conditions: Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Treatments: Procedure: core decompression of the femoral head; Procedure: core decompression with autologous bone marrow implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01544712

Ref 2004/08 st 3

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Control

Active Comparator group

Description:

Core decompression

Treatment:

Procedure: core decompression of the femoral head

Bone marrow

Experimental group

Description:

core decompression plus autologous concentrated bone marrow

Treatment:

Procedure: core decompression with autologous bone marrow implantation