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NCT06123481 · ClinicalTrials.gov registry record · NA

Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

A NA study of Avascular Necrosis of the Femoral Head and Osteonecrosis of the Femoral Head, sponsored by Johns Hopkins University.

Recruiting
Registry status
NA
Development phase
192
Enrollment target
10
Study locations

NCT06123481: Recruiting NA study of Avascular Necrosis of the Femoral Head and Osteonecrosis of the Femoral Head, sponsored by Johns Hopkins University.

NCT06123481 is a NA study of Avascular Necrosis of the Femoral Head and Osteonecrosis of the Femoral Head that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 192 participants, roughly in line with the 202-participant average among 4 other Avascular Necrosis of the Femoral Head trials with a reported enrollment target. The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06123481, a NA study of Avascular Necrosis of the Femoral Head and Osteonecrosis of the Femoral Head, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
NA
Development phase
192 participants
Enrollment target
10
Study locations

Study Summary

Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise to secondary arthritis. This condition is associated with marked pain and loss of function, often necessitating a joint replacement. Due to the relatively young age of onset of ONFH (often in 20s and 30s), there is great interest in utilizing joint-preserving procedures prior to the need for joint replacement. Joint-preserving procedures include core decompression (CD) with and without bone grafts or cells, vascularized and non-vascularized bone grafting, as well as osteotomies. Inconsistent results for each of these procedures have been reported and there are no Clinical Practice Guidelines or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.

Primary Outcome

The 2019 ARCO Staging System encompasses four stages. ARCO Stage I is the earliest stage of osteonecrosis and is characterized by a normal x-ray and an abnormal MRI. ARCO Stage IV is the most advanced stage of osteonecrosis and is characterized by findings of osteoarthritis on x-ray.

Conditions Studied

Avascular Necrosis of the Femoral Head Osteonecrosis of the Femoral Head

Interventions

  • PROCEDURE Core Decompression
  • PROCEDURE Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

Study Locations (10)

California

  • University of Southern California - Los Angeles
  • Stanford University - Stanford

Maryland

  • Sinai Hospital of Baltimore - Baltimore
  • Johns Hopkins University - Baltimore

Minnesota

  • University of Minnesota - Minneapolis
  • Mayo Clinic - Rochester

New York

  • NYU Langone Health Orthopedic Hospital - New York

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2025-04-01
Est. Completion 2029-07-31
Phase NA
Johns Hopkins University

1,448 total trials

What NCT06123481 shows while recruiting

NCT06123481 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 202-participant average among 4 other Avascular Necrosis of the Femoral Head trials with a reported enrollment target.

The record links to 2 conditions, with Avascular Necrosis of the Femoral Head appearing as the primary indexed condition, and to 2 interventions - of which Core Decompression is the first listed.

NCT06123481 lists 10 locations in 7 states (California, Maryland, Minnesota).

Frequently Asked Questions

What is clinical trial NCT06123481 about?

NCT06123481 is a clinical study titled "Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis". Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise ...

What is the current status of trial NCT06123481?

This trial is currently recruiting. It is a NA study. The enrollment target is 192 participants. The study started on 2025-04-01. Estimated completion is 2029-07-31.

What conditions does trial NCT06123481 study?

This clinical trial studies the following conditions: Avascular Necrosis of the Femoral Head, Osteonecrosis of the Femoral Head.

What interventions are being tested in trial NCT06123481?

The interventions under investigation include: Core Decompression (PROCEDURE), Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate (PROCEDURE).

Who is sponsoring clinical trial NCT06123481?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06123481 being conducted?

This trial has 10 study locations across California, Maryland, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06123481

Source: ClinicalTrials.gov NCT06123481, the US trial registry maintained by the National Library of Medicine. NCT06123481 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.