An interventional study of core decompression with local bone marrow mononuclear cells injection in Avascular Necrosis of the Femoral Head, sponsored by Global Stem Cell Center, Baghdad. Completed at 1 site in Iraq. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Global Stem Cell Center, Baghdad · Not applicable, Interventional, and Treatment
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.
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.
65 studies on the registry are indexed under Femur Head Necrosis; 16 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 36 interventional studies indexed under Femur Head Necrosis.
Browse Femur Head Necrosis studies →Global Stem Cell Center, Baghdad is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
clinical improvement
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.
Time frame: 6 months
disease progression
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.
Time frame: around 6 months from starting recruitment
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Global Stem Cell Center, Baghdad