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Procedure

Vanguard XP Bicruciate Knee System for Osteoarthritis (GK9B Trial)

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial will compare two kinds of knee replacement surgery to see if preserving the ligaments results in better function afterward.

Eligible Conditions
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Lower Limb Deformities
  • Post Traumatic Deformity
  • Joint Replacement Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Secondary outcome measures
Modified Knee Society Score
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vanguard XP Bicruciate Knee SystemExperimental Treatment1 Intervention
153 patients receive Vanguard XP Bicruciate Knee System
Group II: Vanguard CR Knee SystemActive Control1 Intervention
153 patients receive Vanguard CR Knee System

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,147 Total Patients Enrolled
129 Trials studying Osteoarthritis
33,074 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,952 Total Patients Enrolled
11 Trials studying Osteoarthritis
3,101 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet
10 Previous Clinical Trials
2,575 Total Patients Enrolled
7 Trials studying Osteoarthritis
2,112 Patients Enrolled for Osteoarthritis
~5 spots leftby Jul 2025