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Procedure

Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (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
No Placebo-Only Group

Summary

This trial compares a new knee replacement system that keeps natural ligaments to a traditional one that removes them. It targets patients needing knee replacements to see if preserving ligaments improves recovery and function over time.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
378 Previous Clinical Trials
68,045 Total Patients Enrolled
136 Trials studying Osteoarthritis
34,518 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,930 Total Patients Enrolled
12 Trials studying Osteoarthritis
3,663 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet
12 Previous Clinical Trials
3,143 Total Patients Enrolled
8 Trials studying Osteoarthritis
2,360 Patients Enrolled for Osteoarthritis
~4 spots leftby Dec 2025
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