Prosthetic-joint InfectionPhase 2Apex-2NCT05607030
A Second Trial of the Abbreviated Protocol Two-Stage Exchange
A Phase 2 study testing VT-X7 Treatment System, Two-stage exchange arthroplasty and SOC Antibiotics in people with Prosthetic-joint Infection, run by Osteal Therapeutics, Inc. at 19 sites in United States.
Trial summary
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Read more about this study
- Who is it for?
- Ages 22 to 84 years
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- VT-X7 Treatment System, Two-stage exchange arthroplasty and SOC Antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 19 sitesUnited States
- Study dates
- 23 Jan 2023to 30 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection (PJI)
- Signed informed consent
- 22 to 84 years of age (inclusive)
- Medical clearance for surgery
- Preoperative diagnosis of PJI of the hip or knee per the International Consensus Meeting of Musculoskeletal Infection (ICMMI) 2018 definition of Periprosthetic Hip and Knee Infection
Who cannot join
- Patients with 2 or more prior exchange arthroplasties (septic or aseptic) of the infected joint. Exchange of modular components only is not considered an exchange arthroplasty;
- Patients with 2 or more prior failed spacers for PJI;
- Patients for whom a Stage 2 procedure within one year is contraindicated;
- Patients with a medical history or current medical condition that requires a planned prescription of suppressive antibiotics to treat PJI of the index joint for > 12 months post Stage-2 surgery;
- Patients with bacteremia or positive bacterial blood culture in the last 30 days;
- Patients with concurrent PJI of more than one joint;
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- Patients with ongoing active infection of an intravenous (IV) site;
- Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition;
- Patients with advanced renal insufficiency (i.e., chronic kidney disease Stage 4 or 5 or patients with an estimated glomerular filtration rate <30 mL/min);
- Patients on chemotherapy for malignant disease;
- Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent);
- Patients who are immunodeficient (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus infection, primary immunodeficiency disease), except patients who are immunodeficient due to immunosuppressive therapy;
- Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate (Note: prior history of red man syndrome is not considered an allergy);
- Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane;
- Patients who are pregnant or planning to become pregnant in the next 12 months;
- Patients with a fungal PJI as determined by one or more positive fluid and/or tissue cultures;
- Patients who have a skeletal defect greater than 150 mm in length in the tibia or femur of the infected joint;
- Patients who have a planned surgical procedure within 6 months of enrollment that can impact the conduct of the study;
- Patients who are breastfeeding;
- Patients who are incarcerated or are facing impending incarceration;
- Patients who have been in treatment or referred to treatment for substance abuse within the past year;
- Patients with any medical condition, including schizophrenia or another psychiatric disorder with hallucinations and/or delusions, that would interfere with the interpretation of the study results, the conduct of the study, or patient participation would not be in the best interest of the patient in the opinion of the Study Site Principal Investigator;
- Patients who will participate in another clinical study of an investigational drug or investigational device or have participated in another clinical study of an investigational drug or investigational device within the past 30 days that would interfere with the interpretation of the study results or the conduct of the study;
- Patients who are judged by the Study Site PI to be unsuitable for the study;
- Patients receiving immunosuppressive drug therapy for bone marrow or another transplant;
- Patients currently or previously enrolled in this study or the APEX study (JPS-0301);
- Patients who receive therapy including any of the following biologic agents, which will not be withheld for a period beginning at least one dosing cycle (minimum 7 days) prior to planned surgery and ending at least 14 days following planned surgery:
- Adalimumab (Humira); Tocilizumab (Actemra); Etanercept (Enbrel); Anakinra (Kineret); Golimumab (Simponi); Secukinumab (Cosentyx); Infliximab (Remicade); Ustekinumab (Stelara); Abatacept (Orencia); Rituximab (Rituxan); Certolizumab (Cimzia); Tofacitinib (Xeljanz); Belimumab (Benlysta)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
OrthoCarolina
Charlotte, North Carolina, 28207
University of Virginia Health
Charlottesville, Virginia, 22903
University of Cincinnati
Cincinnati, Ohio, 45219
Bethesda North Hospital - TriHealth Hatton Research
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65212
The Ohio State University Medical Center
Columbus, Ohio, 43202
Houston Methodist Medical Center
Houston, Texas, 77030
Harbor UCLA Medical Center
Los Angeles, California, 90502
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Langone Health
New York, New York, 10016
INTEGRIS Health Southwest Medical Center
Oklahoma City, Oklahoma, 73109
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Covenant Medical Center
Saginaw, Michigan, 48602
Kennedy White Orthopaedic Center
Sarasota, Florida, 34232
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Second Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.
The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
- Conditions
- Prosthetic-joint Infection
- Being tested
- VT-X7 Treatment System, Two-stage exchange arthroplasty, SOC Antibiotics, Experimental Antibiotics
- Keywords
- Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-X7 Treatment SystemCombination product
Seven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer.
Two-stage exchange arthroplastyProcedure or surgery
Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis.
SOC AntibioticsDrug
Administration of at least 6 weeks of systemic antibiotics post-Stage 1 surgery followed by a 2-week antibiotic holiday before the Stage 2 surgery. After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
Experimental AntibioticsDrug
After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per SOC. Receives: Combination Product: VT-X7 Treatment System; Procedure: Two-stage exchange arthroplasty; Drug: Experimental Antibiotics |
| Control | Active comparator | 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. Receives: Procedure: Two-stage exchange arthroplasty; Drug: SOC Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Treatment Success
- Stage 2 revision prosthesis implanted and
- Absence of PJI post-Stage 2 and
- Absence of continued antibiotic therapy for treatment or prophylaxis of PJI and
- Absence of revision surgery of the affected joint pre- and post-Stage 2 and
- Absence of mortality.
Measured: 180 days
Secondary outcomes (4)
Overall Treatment Success
- Stage 2 revision prosthesis implanted and
- Absence of PJI post-Stage 2 and
- Absence of continued antibiotic therapy for treatment or prophylaxis of PJI and
- Absence of revision surgery of the affected joint pre- and post-Stage 2 and
- Absence of mortality.
Measured: 365 days
Adverse Event Rate
Comparison of the cumulative proportion of subjects with reported adverse events between the study arms.
Measured: 365 days
Quality Adjusted Life Years
Comparison of Quality Adjusted Life Years between the study arms as estimated by EQ-5D-3L.
Measured: 365 days
Survival
Comparison of the survival between the study arms.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start23 Jan 2023
- Primary completion20 May 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Piuzzi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607030
- Sponsor's protocol ID
- OTX-0302
- Acronym
- Apex-2
- Status last verified
- Jan 2025
- First submitted
- 31 Oct 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Second Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
- ClinicalTrials.gov ID
- NCT05607030
- Acronym / sponsor ID
- Apex-2 / OTX-0302
- Conditions
- Prosthetic-joint Infection
- Keywords
- Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Osteal Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.
The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Combination Product: VT-X7 Treatment System, Procedure: Two-stage exchange arthroplasty, Drug: Experimental AntibioticsLocal antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per SOC. |
| Control | Active comparator | Procedure: Two-stage exchange arthroplasty, Drug: SOC AntibioticsSOC 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. |
Who may qualify
- Ages
- 22 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection (PJI)
- Signed informed consent
- 22 to 84 years of age (inclusive)
- Medical clearance for surgery
- Preoperative diagnosis of PJI of the hip or knee per the International Consensus Meeting of Musculoskeletal Infection (ICMMI) 2018 definition of Periprosthetic Hip and Knee Infection
Key exclusion criteria (28 listed)
- Patients with 2 or more prior exchange arthroplasties (septic or aseptic) of the infected joint. Exchange of modular components only is not considered an exchange arthroplasty;
- Patients with 2 or more prior failed spacers for PJI;
- Patients for whom a Stage 2 procedure within one year is contraindicated;
- Patients with a medical history or current medical condition that requires a planned prescription of suppressive antibiotics to treat PJI of the index joint for > 12 months post Stage-2 surgery;
- Patients with bacteremia or positive bacterial blood culture in the last 30 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-X7 Treatment SystemSeven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer. | Combination product | Experimental |
| Two-stage exchange arthroplastyStage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis. | Procedure or surgery | Control, Experimental |
| SOC AntibioticsAdministration of at least 6 weeks of systemic antibiotics post-Stage 1 surgery followed by a 2-week antibiotic holiday before the Stage 2 surgery. After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines. | Drug | Control |
| Experimental AntibioticsAfter Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines. | Drug | Experimental |
Primary outcome
Overall Treatment Success
Time frame: 180 days
* Stage 2 revision prosthesis implanted and * Absence of PJI post-Stage 2 and * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI and * Absence of revision surgery of the affected joint pre- and post-Stage 2 and * Absence of mortality.
4 secondary outcomes
Overall Treatment Success
Time frame: 365 days
Adverse Event Rate
Time frame: 365 days
Quality Adjusted Life Years
Time frame: 365 days
Survival
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Piuzzi, MD principal investigator
The Cleveland Clinic
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-X7 Treatment System, Two-stage exchange arthroplasty and SOC Antibiotics in people with Prosthetic-joint Infection, run by Osteal Therapeutics, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Treatment Success (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.