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Two-Stage Exchange Arthroplasty + VT-X7 for Prosthetic Joint Infection (Apex-2 Trial)
Phase 2
Waitlist Available
Led By Nicolas Piuzzi, MD
Research Sponsored by Osteal Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
Apex-2 Trial Summary
This trial compares the safety and effectiveness of a new medical device for hip/knee replacement surgery. Patients will be randomly assigned to either the experimental or control group.
Who is the study for?
This trial is for adults aged 22-84 with hip or knee infections needing a two-stage exchange arthroplasty. They must understand and agree to the study, be medically cleared for surgery, and meet specific infection criteria. Excluded are those on high-dose steroids, immunodeficient (except from therapy), allergic to certain materials in the device, recently in other drug/device trials, treated for substance abuse within a year, have psychiatric disorders affecting study participation, multiple joint infections or severe kidney issues.Check my eligibility
What is being tested?
The Apex-2 trial tests if the VT-X7 system is better than standard care at treating joint infections after prosthesis implantation. Success includes no infection signs at day 180 post-surgery without antibiotics or additional surgeries and survival of patients. Quality of life will also be assessed up to one year.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include typical surgical risks like infection risk increase due to the device's materials or reactions related to any new technology used during treatment.
Apex-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Event Rate
Overall Treatment Success
Quality Adjusted Life Years
+1 moreApex-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment2 Interventions
Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per SOC.
Group II: ControlActive Control2 Interventions
SOC for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Two-stage exchange arthroplasty
2021
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Osteal Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
91 Total Patients Enrolled
Nicolas Piuzzi, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection at my IV site.I am currently receiving chemotherapy for cancer.I am on drugs to suppress my immune system after a transplant.I am medically cleared for surgery.I am immunodeficient but not because of immunosuppressive therapy.I have a fungal infection in my joint implant, confirmed by positive cultures.I am taking more than 10 mg/day of prednisone or its equivalent.I have severe kidney disease or my kidneys filter blood very slowly.I cannot undergo a second surgery within a year due to health risks.I have a bone defect longer than 150 mm in my leg due to an infection.I need ongoing blood thinner medication and cannot stop or switch it for any reason.I will stop my biologic medication at least 7 days before and not restart for 14 days after surgery.I am between 22 and 84 years old.I have been diagnosed with a joint infection in my hip or knee according to ICMMI 2018.I have had 2 or more unsuccessful spacer treatments for joint infection.I am not pregnant and do not plan to become pregnant in the next year.I have had 2 or more joint replacement surgeries on the same joint.I have a surgery planned within 6 months that may affect this study.I am scheduled for a surgery to treat an infection around my hip or knee replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age requirement for entry into this research project under 25 years old?
"The eligibility rules of this clinical trial state that the minimum age for participants must be at least 22 years old while no more than 84-year-olds can take part."
Answered by AI
How many participants are enrolling in this research project?
"Osteal Therapeutics, Inc. need 76 qualified individuals to complete the trial at two of their selected sites: OrthoCarolina in Charlotte, North carolina and Cleveland Clinic in Cleveland, Ohio."
Answered by AI
Are there any vacancies available in the current research program?
"The available data from clinicaltrials.gov confirms that this research is actively accepting participants, with the trial having been first posted on January 30th 2023 and subsequently updated on January 14th of the same year."
Answered by AI
Do I meet the prerequisites to join this experiment?
"For enrollment in this clinical trial, applicants must be afflicted with prosthetic joint infection and aged between 22 to 84 years old. A total of 76 volunteers are sought out for the study."
Answered by AI
Has the FDA officially sanctioned Experimental?
"We rate the safety of this experimental medication as a 2, due to it being in Phase 2 clinical trials. While there is some evidence supporting its security profile, efficacy evaluation remains pending."
Answered by AI
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