Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Core decompression

Group Type ACTIVE_COMPARATOR

core decompression of the femoral head

Intervention Type PROCEDURE

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

Bone marrow

core decompression plus autologous concentrated bone marrow

Group Type EXPERIMENTAL

core decompression with autologous bone marrow implantation

Intervention Type PROCEDURE

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

Interventions

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core decompression with autologous bone marrow implantation

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

Intervention Type PROCEDURE

core decompression of the femoral head

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No