Avascular NecrosisGenexNCT05706909
The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head
An observational study of Avascular Necrosis and Osteonecrosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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®. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Avascular Necrosis, Osteonecrosis
- What is being tested?
- Genex with ABMC
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Subject is at least 18 years or older with osteonecrosis of the femoral head
- Surgeon considers the patient appropriate for the core decompression procedure of the hip
- Subject provides voluntarily signature on the IRB approved Informed Consent Form
- Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete the study protocol and follow ups
Who cannot join
- Subject is pregnant at the time of surgery
- Subject is incarcerated
- Subject is not comfortable with speaking, reading and understanding questions and providing responses in an available language for the questionnaires provided for the study
Trial locations and contacts
1 site in 1 country.
About this study
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®.
Read the detailed description
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.
- Conditions
- Avascular Necrosis, Osteonecrosis
- Being tested
- Genex with ABMC
- Keywords
- avascular necrosis, osteonecorsis, hip, femoral head
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genex with ABMCDevice
Core decompression, injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the decompression procedure
| Study group | Role | What they receive |
|---|---|---|
| Genex with ABMC | Injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure Receives: Device: Genex with ABMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline X-ray result.
Assessment of bone regeneration
Measured: 6 weeks, 12 weeks, 6 months, 12 months post operatively
Change from baseline MRI result.
Assessment for no further collapse or progression of osteonecrosis
Measured: 12 months
Secondary outcomes (4)
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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start8 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Biocomposites Ltd
- Responsible party
- Principal investigator, Nicolas Piuzzi, The Cleveland Clinic
- Investigators
- Nicolas Piuzzi, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706909
- Sponsor's protocol ID
- 22-580
- Acronym
- Genex
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weinstein RS. Glucocorticoid-induced osteonecrosis. Endocrine. 2012 Apr;41(2):183-90. doi: 10.1007/s12020-011-9580-0. Epub 2011 Dec 15.
PubMed 22169965Yang HL, Zhu XS, Chen L, Chen CM, Mangham DC, Coulton LA, Aiken SS. Bone healing response to a synthetic calcium sulfate/beta-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater. 2012 Oct;100(7):1911-21. doi: 10.1002/jbm.b.32758. Epub 2012 Jul 30.
PubMed 22847979Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM. Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015 Sep 18;6(8):590-601. doi: 10.5312/wjo.v6.i8.590. eCollection 2015 Sep 18.
PubMed 26396935
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT05706909
- Acronym / sponsor ID
- Genex / 22-580
- Conditions
- Avascular Necrosis, Osteonecrosis
- Keywords
- avascular necrosis, osteonecorsis, hip, femoral head
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Biocomposites Ltd
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genex with ABMC | – | Device: Genex with ABMCInjection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Subject is at least 18 years or older with osteonecrosis of the femoral head
- Surgeon considers the patient appropriate for the core decompression procedure of the hip
- Subject provides voluntarily signature on the IRB approved Informed Consent Form
- Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete the study protocol and follow ups
Key exclusion criteria (3 listed)
- Subject is pregnant at the time of surgery
- Subject is incarcerated
- Subject is not comfortable with speaking, reading and understanding questions and providing responses in an available language for the questionnaires provided for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genex with ABMCCore decompression, injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the decompression procedure | Device | Genex with ABMC |
Primary outcome
Change from baseline X-ray result.
Time frame: 6 weeks, 12 weeks, 6 months, 12 months post operatively
Assessment of bone regeneration
Change from baseline MRI result.
Time frame: 12 months
Assessment for no further collapse or progression of osteonecrosis
4 secondary outcomes
Numeric Pain Scale
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Modified Harris Hip Score
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Hip Outcome Score
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
EQ-5D-5L Score
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 22169965Weinstein RS. Glucocorticoid-induced osteonecrosis. Endocrine. 2012 Apr;41(2):183-90. doi: 10.1007/s12020-011-9580-0. Epub 2011 Dec 15.
- Background: PubMed 22847979Yang HL, Zhu XS, Chen L, Chen CM, Mangham DC, Coulton LA, Aiken SS. Bone healing response to a synthetic calcium sulfate/beta-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater. 2012 Oct;100(7):1911-21. doi: 10.1002/jbm.b.32758. Epub 2012 Jul 30.
- Results publication: PubMed 26396935Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM. Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015 Sep 18;6(8):590-601. doi: 10.5312/wjo.v6.i8.590. eCollection 2015 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Piuzzi principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis and Osteonecrosis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline X-ray result. (time frame: 6 weeks, 12 weeks, 6 months, 12 months post operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706909, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.