Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

University of Liege50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Interventions

core decompression with autologous bone marrow implantationPROCEDURE

core biopsy with injection of 40 ml concentrated autologous bone marrow.

core decompression of the femoral headPROCEDURE

core biopsy with injection of 40 ml saline solution in place of bone marrow.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Liège

Liège, Liège, Belgium

Outcomes

Primary Outcomes

reduction of total prosthesis

Need to undergo a surgical treatment total prosthesis

Time frame: 24, 60 months

Secondary Outcomes

Pain reduction

Visual analogue scale

Time frame: 24, 60 months

functional status

Lequesne and WOMAC scores

Time frame: 24, 60 months

Data from ClinicalTrials.gov

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