The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head
(Genex Trial)
Recruiting in Palo Alto (17 mi)
NP
Overseen byNicolas Piuzzi
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
No Placebo Group
Trial Summary
What is the purpose of this trial?
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®.
Research Team
NP
Nicolas Piuzzi
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
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
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
See 1 more
Treatment Details
Interventions
- Genex (Bone Graft Substitute)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Genex with ABMCExperimental Treatment1 Intervention
Injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Trials
1,072
Recruited
1,377,000+
David Peter
The Cleveland Clinic
Chief Medical Officer
MD, board-certified in Hospice and Palliative Medicine
Tomislav Mihaljevic
The Cleveland Clinic
Chief Executive Officer since 2018
MD from University of Zagreb School of Medicine
Biocomposites Ltd
Industry Sponsor
Trials
6
Recruited
270+