Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Participants who have non-traumatic osteonecrosis of the femoral head

• Only participants who have Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System

• No evidence of subchondral fracture

• All osteonecrotic lesion sizes

• All major risk factors (e.g. corticosteroids, alcohol, organ recipient) except for those listed in the exclusion criteria

• Participants diagnosed who have femoral head osteonecrosis for which no risk factor has yet to be identified

• Participants will include all ethnicities and races

• Be able and willing to participate in study and return for postoperative visits

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Stanford University
RECRUITING
Stanford
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
New York
NYU Langone Health Orthopedic Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Lynne C Jones, PhD
ljones3@jhmi.edu
(410) 550-4001
Backup
Stuart Goodman, MD, PhD
goodbone@stanford.edu
650-721-7662
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 192
Treatments
Active_comparator: Core decompression (CD)
Core decompression of the femoral head with sham bone marrow aspiration
Experimental: Bone Marrow Aspirate Concentrate (BMAC)
Autologous bone marrow aspiration is concentrated and injected into the necrotic bone of the femoral head through the core decompression opening.
Sponsors
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov