An observational study in Avascular Necrosis and Osteonecrosis, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by The Cleveland Clinic · Observational
The purpose of this study is to assess the clinical and x-ray results of patients who are treated with core decompression of the hip and the injection of a bone marrow concentrate and the use of the Bone Graft Substitute Genex®.
Avascular necrosis (AVN) or osteonecrosis (ON) of the femoral head refers to a condition in bone metabolism when cells of the trabecular bone (porous bone found at the end of long bones like the femur) in the hip spontaneously die. Depending on the amount of femoral head involvement, parts of the surface, like the articular surface that do not have blood vessels may collapse as the disease advances. Although the exact common occurrence of AVN or ON is unknown, the incidence is estimated to be between 20,000 to 30,000 newly diagnosed patients each year in the US.
Core decompression of the hip is a minimally invasive surgical technique performed to manage symptoms in early stages (precollapse) of the condition. The procedure involves drilling holes into the femoral head to relieve pressure and create channels for new blood vessels to nourish the affected areas. Multiple adjuncts to core decompression, such as structural bone grafts, bone marrow concentrates, and bone proteins have been developed to accelerate the healing process in these patients. In recent years, considerable research activity has also been expanded to find new bone substitutes with osteoconductive properties (where bone grows on a surface) for the use in the treatment of surgically created defects.
Genex® Bone Graft Substitute is a catalyst for bone healing. It complements the body's natural healing processes and encourages normal bone structure to be restored at a steady rate. Over 12 months, the graft matrix is completely absorbed and replaced by bone. No foreign artifacts are left behind to impair structural integrity.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's enrollment of 22 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are 18 years or older with early osteonecrosis of the femoral head and meet the inclusion and exclusion criteria based on the protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure
Device: Genex with ABMC
Core decompression, injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the decompression procedure
Change from baseline X-ray result.
Assessment of bone regeneration
Time frame: 6 weeks, 12 weeks, 6 months, 12 months post operatively
Change from baseline MRI result.
Assessment for no further collapse or progression of osteonecrosis
Time frame: 12 months
Numeric Pain Scale
To assess pain using the Numeric Pain Scale on a scale of 0-10 with 10 being the worst possible pain report and 0 being no pain
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Modified Harris Hip Score
To evaluate the success of the core decompression procedure using the Modified Harris Hip Score by adding up the assigned points for each question, divided by a maximum score of (91) x 100 to create a percentage. A higher score equals a higher level of physical function (100% = full function).
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Hip Outcome Score
To assess the outcome of the treatment intervention using the Hip Outcome Score with five possible responses, graded from 0 to 4 with 4 being no difficulty at all and 0 unable to do in regard to physical limitations.
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
EQ-5D-5L Score
To assess aspects of mobility, self-care, usual activities, pain/discomfort and anxiety/depression using the EQ-5D-5L tool. The EQ-5D-5L descriptive system uses (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 46 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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