Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

Bone Marrow Clinical Trial

Official title:

The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787329
• Other study ID #: RD-106057
• Status: Recruiting
• Start date: April 14, 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Show Chwan Memorial Hospital
• Contact: Chang-Han Chuang, MD
• Phone: +886-975611794
• Email: skyman889[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Femur
• Bone Marrow
• Necrosis
• Osteonecrosis

Intervention

Other:
• Core decompression surgery with bone marrow concentration
Core decompression surgery with bone marrow concentration
• Core decompression surgery
Core decompression surgery only

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month postoperative hip function evaluated by Harris Hip Score	Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	3-month postoperative
Secondary	6-month postoperative hip function evaluated by Harris Hip Score	Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	6-month postoperative
Secondary	12-month postoperative hip function evaluated by Harris Hip Score	Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	12-month postoperative
Secondary	3-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	3-month postoperative
Secondary	6-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	6-month postoperative
Secondary	12-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	12-month postoperative
Secondary	6-month postoperative degree of collapse evaluated by MRI	Degree of collapse is evaluated by MRI	6-month postoperative