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Bone Marrow Cells With Core Decompression for AVN Treatment

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ClinicalTrials.gov Identifier: NCT05982054
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
abdulmajeed hammadi, Global Stem Cell Center, Baghdad

Study Description
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Brief Summary:
Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this is a single armed study to be done from July 2023 till January 2024, the total number of patients anticipated is 10, total joints treated around 20, The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Condition or disease Intervention/treatment Phase
Avascular Necrosis of the Femoral Head Procedure: core decompression with local bone marrow mononuclear cells injection Not Applicable

Detailed Description:
Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. Early stage AVN can be managed by various techniques, the results have been disappointing, total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. This procedure is usually a high risk procedure under general anesthesia ,with The newer treatment modalities include using high stem cell concentration in the vicinity of the necrosed tissue with core decompression to prevent disease progression. this study is a single armed study to be done from July 2023 to January 2024, the total number of patients is 10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Autologous Bone Marrow Cells With Core Decompression for Treating Avascular Hip Necrosis Under Local Anesthesia
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : January 24, 2024
Estimated Study Completion Date : January 24, 2024
Arms and Interventions
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Arm Intervention/treatment
bone marrow injection
injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression
 Procedure: core decompression with local bone marrow mononuclear cells injection
under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide


Outcome Measures
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Primary Outcome Measures :
  1. clinical improvement [ Time Frame: 6 months ]
    change in Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad.


Secondary Outcome Measures :
  1. disease progression [ Time Frame: around 6 months from starting recruitment ]
    percentage of patients who have clinical progress using Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad or radiological proof of disease progression by Mitchell classification which is used to stage osteonecrosis of the femoral head and is based on MRI signal characteristics within the center of the lesion and classified into four stages with stage A representing early disease and stage D representing late disease.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Avascular hip necrosis irrespective Of stage.
  2. age from 25-55 years. -

Exclusion Criteria:

  1. history of bleeding tendency.
  2. history of malignant disease.
  3. critically ill patient. -
Contacts and Locations
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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): NCT05982054


Contacts
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Contact: abdulmajeed A hammadi, MD +9647902268105 majeed51578@yahoo.co.uk
Contact: khalil J kareem, MD +9647803977072 khaliljumakareem69@gmail.com

Locations
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Iraq
Ministry of Health Recruiting
Baghdad, Iraq, 964
Contact: thamer M alrubaie, MD    +9647700009294    alzaitounhospital@gmail.com   
Sponsors and Collaborators
Global Stem Cell Center, Baghdad
Investigators
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Principal Investigator: abdulmajeed a hammadi, MD clinical stem cell studies
More Information
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Responsible Party: abdulmajeed hammadi, GSCCBaghdad, Global Stem Cell Center, Baghdad
ClinicalTrials.gov Identifier: NCT05982054    
Other Study ID Numbers: KM protocol
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023

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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 abdulmajeed hammadi, Global Stem Cell Center, Baghdad:
avascular necrosis of the femoral head
core decompression
bone marrow cells
local anesthesia
Additional relevant MeSH terms:
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Femur Head Necrosis
Necrosis
Pathologic Processes
 Osteonecrosis
Bone Diseases
Musculoskeletal Diseases