Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Zimmer Biomet50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Lower Limb Deformity Post-traumatic Deformity Complications, Arthroplasty

Interventions

Vanguard XP Bicruciate Knee SystemDEVICE

The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.

Vanguard CR Knee SystemDEVICE

The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Midwest Orthopaedics at Rush University Medical Center

Chicago, Illinois, United States

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 Months

Secondary Outcomes

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.

Time frame: 12 months

Revisions/Removals

Number of study device revisions or removals reported during the study.

Time frame: 3 years

Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)

Time frame: 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."

Time frame: 12 Months

Data from ClinicalTrials.gov

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