NCT05982054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

July 18, 2023

Last Update Submit

July 28, 2024

Conditions

Avascular Necrosis of the Femoral Head

Keywords

avascular necrosis of the femoral headcore decompressionbone marrow cellslocal anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • disease progression

    around 6 months from starting recruitment

Study Arms (1)

bone marrow injection

OTHER

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

Interventions

core decompression with local bone marrow mononuclear cells injectionPROCEDURE

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

bone marrow injection

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health

Baghdad, 964, Iraq

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • abdulmajeed a hammadi, MD

    clinical stem cell studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GSCCBaghdad

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 8, 2023

Study Start

August 10, 2023

Primary Completion

July 28, 2024

Study Completion

July 28, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

IR(1)