Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

Pei-Yuan Lee, MD

Status: Unknown

Conditions: Bone Marrow; Avascular Necrosis of Femur

Treatments: Other: Core decompression surgery; Other: Core decompression surgery with bone marrow concentration

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03787329

RD-106057

Details and patient eligibility

About

This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.

Full description

Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 30 and 60 years
• With diagnosis of avascular necrosis of femoral head, Stage I - Stage III

Exclusion criteria

• With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
• With prior history of hip surgery
• With current or prior history of trauma or infection at hip
• Platelet count < 50,000/µL
• With current diagnosis of coagulopathy
• With current or prior history of cancer
• With current or prior history of hematological disease
• Pregnancy
• Patients who will not cooperate with one-year followup

Trial design

40 participants in 2 patient groups

Bone marrow concentration group

Description:

The patients receive core decompression surgery with bone marrow concentration.

Treatment:

Other: Core decompression surgery with bone marrow concentration

Historical control group

Description:

The previous age-, gender-, and stage-matched patients who received core decompression surgery only.

Treatment:

Other: Core decompression surgery