Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Avascular Necrosis of Femur Bone Marrow

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone marrow concentration group

The patients receive core decompression surgery with bone marrow concentration.

Core decompression surgery with bone marrow concentration

Intervention Type OTHER

Core decompression surgery with bone marrow concentration

Historical control group

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

Core decompression surgery

Intervention Type OTHER

Core decompression surgery only

Interventions

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Core decompression surgery with bone marrow concentration

Intervention Type OTHER

Core decompression surgery

Core decompression surgery only

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No