Bone Marrow Cells With Core Decompression for AVN Treatment

Avascular Necrosis of the Femoral Head Clinical Trial

Official title:

Percutaneous Autologous Bone Marrow Cells With Core Decompression for Treating Avascular Hip Necrosis Under Local Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982054
• Other study ID #: KM protocol
• Status: Recruiting
• Phase: N/A
• 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
• 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. -

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Femur Head Necrosis
• Necrosis

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