Using Genex to treat early-stage osteonecrosis of the femoral head
The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head
This study is testing if a new treatment using a special bone graft and a surgery to relieve pressure can help people with early-stage osteonecrosis of the femoral head heal better over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05706909 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and x-ray outcomes of patients with early-stage osteonecrosis of the femoral head who undergo core decompression surgery combined with the injection of bone marrow concentrate and the Genex® bone graft substitute. Avascular necrosis is a condition where bone cells die due to lack of blood supply, leading to potential collapse of the femoral head. The core decompression technique aims to relieve pressure and promote blood flow to the affected area, while Genex® is designed to enhance the healing process. The study will track patient progress over a 12-month period to assess the effectiveness of this combined approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with osteonecrosis of the femoral head who are suitable for core decompression surgery.
Not a fit: Patients who are pregnant, incarcerated, or unable to understand the study's requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing and outcomes for patients with early-stage osteonecrosis of the femoral head.
How similar studies have performed: Previous studies have shown promise with similar interventions, but the specific use of Genex® in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Nicolas Piuzzi — The Cleveland Clinic
- Study coordinator: Alison Klika
- Email: klikaa@ccf.org
- Phone: 216-444-4954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.