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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Avascular Necrosis of Femur Head

Treatments: Procedure: Enriched BMCs implantation combined with core decompression; Procedure: core decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT01613612

GGH_201112_Ortho_1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

control group:core decompression

Sham Comparator group

Description:

single core decompression

Treatment:

Procedure: core decompression

Treatment group: BMCs+core decompression

Active Comparator group

Description:

Enriched bone marrow cells combined with core decompression

Treatment:

Procedure: Enriched BMCs implantation combined with core decompression