Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Marrow; Avascular Necrosis of Femur
• Intervention / Treatment: Other: Core decompression surgery with bone marrow concentration; Other: Core decompression surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Recruiting
      • Show Chwan Memorial Hospital
      • Contact: Chang-Han Chuang, MD; Phone Number: +886-975611794; Email: skyman889@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive eligible patients who underwent core decompression combined with autologous bone marrow stem cells treatment for avascular necrosis of the femoral head

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bone marrow concentration group; The patients receive core decompression surgery with bone marrow concentration.	Other: Core decompression surgery with bone marrow concentration; Core decompression surgery with bone marrow concentration
Historical control group; The previous age-, gender-, and stage-matched patients who received core decompression surgery only.	Other: Core decompression surgery; Core decompression surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
3-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	3-month postoperative
6-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	6-month postoperative
12-month postoperative degree of collapse evaluated by plain radiograph	Degree of collapse is evaluated by plain radiograph	12-month postoperative
6-month postoperative degree of collapse evaluated by MRI	Degree of collapse is evaluated by MRI	6-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: December 22, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Mesenchymal Stromal Cells; Bone Marrow; Femur Head Necrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis
• Other Study ID Numbers: RD-106057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No