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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer.
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.
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).
Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.
University of Arizona, Phoenix
Phoenix, Arizona, United States
Harbor-UCLA Medical Center
Torrance, California, United States
VA Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Cleveland Clinic
Weston, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Covenant Medical Center
Saginaw, Michigan, United States
New York University
New York, New York, United States
Columbia
New York, New York, United States
OrthoCarolina Research Institute, Inc
Charlotte, North Carolina, United States
...and 7 more locations
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.
Time frame: 90 days
Composite endpoint of Overall Success at 180 days
Composite endpoint of Overall Success at 180 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI \*\*; * Absence of reoperation\*\*\* of the affected joint pre- and post-Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Continued antibiotic therapy includes antibiotic therapy at 180 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI. * Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.
Time frame: 180 days
Composite endpoint of Overall Success at 365 days consisting of:
Composite endpoint of Overall Success at 365 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI \*\*; * Absence of reoperation\*\*\* of the affected joint pre- and post-Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Continued antibiotic therapy includes antibiotic therapy at 365 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI. * Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.
Time frame: 365 days
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