The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head

Launched by THE CLEVELAND CLINIC · Jan 23, 2023

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ClinConnect Summary

This clinical trial is studying a treatment for patients with early-stage osteonecrosis of the femoral head, a condition where the bone in the hip loses blood supply and can lead to joint pain and mobility issues. The researchers want to see how effective a procedure called core decompression, combined with an injection of bone marrow concentrate and a special bone graft substitute called Genex®, is in helping patients feel better and improve their hip health.

To join this study, participants need to be at least 18 years old and have osteonecrosis of the hip that their surgeon believes can be treated with core decompression. They should also be willing to follow the study guidelines and attend follow-up appointments. Unfortunately, pregnant individuals, those who are incarcerated, or anyone who has difficulty understanding the study materials will not be eligible. If you participate, you can expect to undergo the treatment and have regular check-ups to monitor your progress through imaging and assessments. This trial is currently looking for participants, so it could be a great opportunity for those seeking help with this condition.

Gender

ALL

Eligibility 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