ACTIVE_NOT_RECRUITING

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

Conditions

Avascular Necrosis Osteonecrosis osteonecorsis hip femoral head

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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®.

Official Title

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

Quick Facts

Study Start:2023-02-08

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05706909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Nicolas Piuzzi

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Nicolas Piuzzi, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-08

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-02-08

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

avascular necrosis
osteonecorsis
hip
femoral head

Additional Relevant MeSH Terms

Avascular Necrosis
Osteonecrosis