Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 3-month postoperative hip function evaluated by Harris Hip Score [3-month postoperative]
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.
Secondary Outcome Measures
- 6-month postoperative hip function evaluated by Harris Hip Score [6-month postoperative]
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 hip function evaluated by Harris Hip Score [12-month postoperative]
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 degree of collapse evaluated by plain radiograph [3-month postoperative]
Degree of collapse is evaluated by plain radiograph
- 6-month postoperative degree of collapse evaluated by plain radiograph [6-month postoperative]
Degree of collapse is evaluated by plain radiograph
- 12-month postoperative degree of collapse evaluated by plain radiograph [12-month postoperative]
Degree of collapse is evaluated by plain radiograph
- 6-month postoperative degree of collapse evaluated by MRI [6-month postoperative]
Degree of collapse is evaluated by MRI
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 30 and 60 years
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With diagnosis of avascular necrosis of femoral head, Stage I - Stage III
Exclusion Criteria:
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With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
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With prior history of hip surgery
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With current or prior history of trauma or infection at hip
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Platelet count < 50,000/µL
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With current diagnosis of coagulopathy
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With current or prior history of cancer
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With current or prior history of hematological disease
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Pregnancy
-
Patients who will not cooperate with one-year followup
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Show Chwan Memorial Hospital | Changhua City | Changhua | Taiwan | 500 |
Sponsors and Collaborators
- Pei-Yuan Lee, MD
- Aeon Biotechnology Corporation
Investigators
- Study Chair: Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD-106057