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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

GK9B Trial 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

GK9B Trial 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

GK9B 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
67,345 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
2,650 Total Patients Enrolled
7 Trials studying Osteoarthritis
2,112 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants to join this research project?

"According to the clinicaltrials.gov database, this particular trial is no longer recruiting patients and has not been updated since August 31st 2021. However, there are an abundance of other medical studies currently enrolling participants with 1060 active opportunities available at present."

Answered by AI
~5 spots leftby Apr 2025