Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Not Applicable

Terminated

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

Interventions: Device: Vanguard XP Bicruciate Knee System
Device: Vanguard CR Knee System

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vanguard XP Bicruciate Knee System	Vanguard XP Bicruciate Knee System	153 patients receive Vanguard XP Bicruciate Knee System
Vanguard CR Knee System	Vanguard CR Knee System	153 patients receive Vanguard CR Knee System

Primary Outcome Measures

Name	Time	Method
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)	12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)	12 Months	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.
Revisions/Removals	3 years	Number of study device revisions or removals reported during the study.
Modified Knee Society Score	12 months	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.
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"	12 Months	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."

Locations (2): Midwest Orthopaedics at Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Utah Orthopaedic Center
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Salt Lake City, Utah, United States