Bone Marrow Cells With Core Decompression for AVN Treatment

Global Stem Cell Center, Baghdad

Status: Completed

Conditions: Avascular Necrosis of the Femoral Head

Treatments: Procedure: core decompression with local bone marrow mononuclear cells injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05982054

KM protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

bone marrow injection

Other group

Description:

injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression

Treatment:

Procedure: core decompression with local bone marrow mononuclear cells injection