Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (GK9B)

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Lower Limb Deformity; Complications, Arthroplasty; Post-traumatic Deformity
• Intervention / Treatment: Device: Vanguard XP Bicruciate Knee System; Device: Vanguard CR Knee System

Detailed Description

Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60605
      • Midwest Orthopaedics at Rush University Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cemented application of components
• bilateral subjects randomized by knee
• patients with pre-existing contralateral knee surgery
• painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
• correction of varus, valgus, or posttraumatic deformity
• sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

Exclusion Criteria:

• cementless application of components
• BMI greater than or equal to 40
• use of Anterior Stabilized Bearings
• patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
• correction or revision of previous joint replacement procedure on index knee
• infection
• sepsis
• osteomyelitis

Relative exclusion criteria:

• uncooperative patient or patient with neurological disorders who is incapable of following directions
• osteoporosis
• metabolic disorders which may impair bone formation
• osteomalacia
• distant foci of infections which may spread to the implant site
• rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
• vascular insufficiency, muscular atrophy, neuromuscular disease
• incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vanguard XP Bicruciate Knee System; 153 patients receive Vanguard XP Bicruciate Knee System	Device: Vanguard XP Bicruciate Knee System; The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Active Comparator: Vanguard CR Knee System; 153 patients receive Vanguard CR Knee System	Device: Vanguard CR Knee System; The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)	Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Knee Society Score	The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes.	12 months
Revisions/Removals	Number of study device revisions or removals reported during the study.	3 years
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)	Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.	12 Months
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"	Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy."	12 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Congenital Abnormalities
• Other Study ID Numbers: ORTHO.CR.GK9B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO