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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05982054
Other study ID # KM protocol
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2023
Est. completion date July 10, 2024

Study information

Verified date March 2024
Source Global Stem Cell Center, Baghdad
Contact abdulmajeed A hammadi, MD
Phone +9647902268105
Email majeed51578@yahoo.co.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 10, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 55 Years
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
core decompression with local bone marrow mononuclear cells injection
under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide

Locations

Country Name City State
Iraq Ministry of Health Baghdad

Sponsors (1)

Lead Sponsor Collaborator
Global Stem Cell Center, Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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. around 6 months from starting recruitment
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