Abbreviated Protocol for Two-Stage Exchange

NCT04662632 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: JPS-0301
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 17

Brief 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

Keywords

Hip; Knee; Biofilm; Minimum-biofilm-eradication-concentration

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint of Overall Success at 90 Days

  Composite endpoint of Overall Success at 90 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of reoperation\*\*\* of the affected joint pre- or post- Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use the International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Reoperation includes only procedures to irrigate, debride, and remove or replace the Stage 1 spacer or any Stage 2 implant component.

  90 days

Secondary Outcomes (2)

• Composite Endpoint of Overall Success at 180 Days

  180 days

• Composite Endpoint of Overall Success at 365 Days Consisting of:

  365 days

Study Arms (2)

Experimental

EXPERIMENTAL

Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care.

Combination Product: VT-X7 Treatment System with Tobramycin Sulfate; Procedure: Two-stage exchange arthroplasty; Combination Product: VT-X7 Treatment System with Vancomycin Hydrochloride

Control

ACTIVE COMPARATOR

Standard of care 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.

Drug: Standard of Care; Procedure: Two-stage exchange arthroplasty

Interventions

VT-X7 Treatment System with Tobramycin Sulfate COMBINATION_PRODUCT

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

Experimental

Standard of Care DRUG

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.

Control

Two-stage exchange arthroplasty PROCEDURE

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).

Control; Experimental

VT-X7 Treatment System with Vancomycin Hydrochloride COMBINATION_PRODUCT

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

Experimental

Eligibility Criteria

• Age: 22 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for two-stage exchange arthroplasty due to hip or knee PJI
• Signed informed consent
• 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 2018 definition of Periprosthetic Hip and Knee Infection

You may not qualify if:

• Patients with 2 or more prior one-stage or two-stage exchange arthroplasties of the infected joint;
• Patients with acute PJI, defined as total joint arthroplasty surgery within 4 weeks prior to enrollment (Stage 1) in this study;
• Patients with bacteremia or positive bacterial blood culture in the last 30 days;
• Patients with concurrent PJI of more than one joint;
• Patients with ongoing active infection of an intravenous 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 (chronic kidney disease Stage 4 or greater or glomerular filtration rate \<30 mL/min);
• Patients on chemotherapy for malignant disease;
• Patients on systemic glucocorticoid therapy (prednisone \>10 mg/day or equivalent);
• Patients with immunodeficiency (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus infection, primary immunodeficiency disease, except immunodeficiency 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 in whom negative pressure wound therapy is contraindicated;
• Patients with a fungal PJI;

Sponsors & Collaborators

• Osteal Therapeutics, Inc.: lead

Study Sites (17)

University of Arizona, Phoenix

Phoenix, Arizona, 85004, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

New York University

New York, New York, 10003, United States

Location

Columbia

New York, New York, 10032, United States

Location

OrthoCarolina Research Institute, Inc

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43202, United States

Location

Integris Southwest Medical Center

Oklahoma City, Oklahoma, 73103, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Health Presbyterian

Plano, Texas, 75093, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

UVA Orthopedics Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Interventions

Tobramycin; Standard of Care; Vancomycin

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: VP, Clinical Affairs
• Organization: Osteal Therapeutics

ccohorn@ostealtx.com

2149579353

Study Officials

• Bryan Springer, MD

  Ortho Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to their randomization arm assignment until the completion of Stage 1 surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: November 1, 2021
• Primary Completion: March 13, 2023
• Study Completion: December 22, 2023
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)