Bone Marrow Cells With Core Decompression for AVN Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis of the Femoral Head
• Intervention / Treatment: Procedure: core decompression with local bone marrow mononuclear cells injection

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 964
    • Ministry of health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Global Stem Cell Center, Baghdad
• Investigators: Principal Investigator: abdulmajeed a hammadi, MD, clinical stem cell studies

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): July 28, 2024
• Study Completion (Actual): July 28, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: local anesthesia; bone marrow cells; core decompression; avascular necrosis of the femoral head
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis; Necrosis; Femur Head Necrosis
• Other Study ID Numbers: KM protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No