Study Type: A multi-site, parallel group, randomized trial.
Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of
VT-X7. 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 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 (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.
Phase:
Phase 2
Details
Lead Sponsor:
Joint Purification Systems Osteal Therapeutics, Inc.