Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)

Guangdong Provincial People's Hospital60 enrolled

Overview

The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Avascular Necrosis of Femur Head

Interventions

core decompressionPROCEDURE

minimal surgical invention to drill a core to the femoral head to release pressure

Enriched BMCs implantation combined with core decompressionPROCEDURE

Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * femoral head necrosis patients * stage I/II/III (Ficat) * age from 18 to 55 years * stop steroid treatment for minimal 6 months Exclusion Criteria: * age younger than 18 or older than 55 * any hemopathy * tumor * femoral head/neck fracture

Outcomes

Primary Outcomes

change of Visual Analogue Scale

Change from baseline in 24 months

Time frame: before invention and 24 months after invention

change of lequensne algofunctional index

change from baseline in 24 months

Time frame: before invention and 24 months after invention

change of WOMAC index

change from baseline in 24 months

Time frame: before invention and 24 months after invention

Data from ClinicalTrials.gov

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