Clinical trial NCT03787329: Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head
Official title: The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Avascular Necrosis of Femur
Bone Marrow
Keywords: Femur Head Necrosis
Mesenchymal Stromal Cells
Bone Marrow
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2018-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-month postoperative hip function evaluated by Harris Hip Score
timeFrame: 3-month postoperative
Secondary outcomes:
measure: 6-month postoperative hip function evaluated by Harris Hip Score
timeFrame: 6-month postoperative
measure: 12-month postoperative hip function evaluated by Harris Hip Score
timeFrame: 12-month postoperative
measure: 3-month postoperative degree of collapse evaluated by plain radiograph
timeFrame: 3-month postoperative
measure: 6-month postoperative degree of collapse evaluated by plain radiograph
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of collapse evaluated by plain radiograph
timeFrame: 12-month postoperative
measure: 6-month postoperative degree of collapse evaluated by MRI
timeFrame: 6-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: