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Trial record 3 of 1807 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

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ClinicalTrials.gov Identifier: NCT03787329
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

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
Avascular Necrosis of Femur Bone Marrow 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. 3-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 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 :
  1. 6-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 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.

  2. 12-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 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. 3-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of collapse is evaluated by plain radiograph

  4. 6-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by plain radiograph

  5. 12-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of collapse is evaluated by plain radiograph

  6. 6-month postoperative degree of collapse evaluated by MRI [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by MRI



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787329


Contacts
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Contact: Chang-Han Chuang, MD +886-975611794 skyman889@gmail.com

Locations
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Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Chang-Han Chuang, MD    +886-975611794    skyman889@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
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Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

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Responsible Party: Pei-Yuan Lee, MD, Superintendent, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03787329     History of Changes
Other Study ID Numbers: RD-106057
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Femur Head Necrosis
Mesenchymal Stromal Cells
Bone Marrow

Additional relevant MeSH terms:
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Necrosis
Osteonecrosis
Femur Head Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases