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A Second Trial of the Abbreviated Protocol Two-Stage Exchange

NCT05607030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-01-07

No results posted yet for this study

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. 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

Interventions

COMBINATION_PRODUCT

VT-X7 Treatment System

Seven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer.

PROCEDURE

Two-stage exchange arthroplasty

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.

DRUG

SOC Antibiotics

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.

DRUG

Experimental Antibiotics

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.

Sponsors & Collaborators

  • Osteal Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicolas Piuzzi, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2024-05-20
Completion
2024-10-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607030 on ClinicalTrials.gov