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Abbreviated Protocol for Two-Stage Exchange

NCT04662632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-21

Study results available
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Summary

Study Type: A multi-site, parallel group, randomized trial.

Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life 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 with Tobramycin Sulfate

Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer.

DRUG

Standard of Care

Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines.

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, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).

COMBINATION_PRODUCT

VT-X7 Treatment System with Vancomycin Hydrochloride

Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.

Sponsors & Collaborators

  • Osteal Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Springer, MD · Ortho Carolina

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
2021-11-01
Primary Completion
2023-03-13
Completion
2023-12-22
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 NCT04662632 on ClinicalTrials.gov