NCT05982054

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Global Stem Cell Center, Baghdad · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Avascular Necrosis of the Femoral Head

Interventions

Type	Name	Description
PROCEDURE	core decompression with local bone marrow mononuclear cells injection	under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-07-28
• Completion: 2024-07-28
• First posted: 2023-08-08
• Last updated: 2024-07-30

Locations

1 site across 1 country: Iraq