Bone Marrow Cells With Core Decompression for AVN Treatment

Not Applicable

Completed

• Conditions: Avascular Necrosis of the Femoral Head
• Interventions: Procedure: core decompression with local bone marrow mononuclear cells injection

• Registration Number: NCT05982054
• Lead Sponsor: Global Stem Cell Center, Baghdad

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.

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 Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-08
• Study Start: 2023-08-10
• Status Verified: 2024-07
• Primary Completion: 2024-07-28
• Study Completion: 2024-07-28
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bone marrow injection	core decompression with local bone marrow mononuclear cells injection	injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression

Primary Outcome Measures

Name	Time	Method
clinical improvement	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

Name	Time	Method
disease progression	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.

Trial Locations

Locations (1)

Ministry of Health; 🇮🇶 Baghdad, Iraq