Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

Conditions

• Avascular Necrosis of the Femoral Head
• Osteonecrosis of the Femoral Head

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Core Decompression — PROCEDURE
  Standard core decompression procedure is performed by drilling into the necrotic bone of the femoral head. A sham bone marrow aspiration involves advancing a needle to the iliac crest (no bone penetration, no bone marrow aspiration) through a small skin incision.
• Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate — PROCEDURE
  This involves bone marrow aspiration, concentrating the bone marrow aspirate, and injecting 6 milliliters of bone marrow aspirate concentrate into the necrotic femoral head through an opening created by the core decompression.

Study Details

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.

Key Dates

Start date

Apr 1, 2025

Status verified

Nov 2025

Primary completion

Mar 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

192 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Radiological progression of osteonecrosis of the femoral head (ONFH) to ARCO Stage III or IV [ Time Frame: Up to 24 months ]

Central Contacts

• Lynne C Jones, PhD
  (410) 550-4001
  [email protected]
• Stuart Goodman, MD, PhD
  650-721-7662
  [email protected]

Locations (10)

Find similar trials in Los Angeles, CA

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