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Completed

NCT Number: NCT05982054

Bone Marrow Cells With Core Decompression for AVN Treatment

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.

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Key information

Conditions

Avascular Necrosis of the Femoral Head Bone Diseases Femur Head Necrosis Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health

Baghdad, 964, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Avascular hip necrosis irrespective Of stage.
  • age from 25-55 years. -

Exclusion criteria

  • history of bleeding tendency.
  • history of malignant disease.
  • critically ill patient. -

Treatment and study plan

core decompression with local bone marrow mononuclear cells injection

Procedure

under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide

Primary outcomes

  1. clinical improvement

    Time frame: 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 outcomes

  1. disease progression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Global Stem Cell Center, Baghdad

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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