NCT04662632

Abbreviated Protocol for Two-Stage Exchange

A Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection (PJI) of the Hip or Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Osteal Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years – 84 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-03-13
• Completion: 2023-12-22
• First posted: 2020-12-10
• Last updated: 2024-04-02

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study