Clinical trial NCT02175576: Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Official title: Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Lower Limb Deformity
Post-traumatic Deformity
Complications, Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
timeFrame: 12 Months
Secondary outcomes:
measure: Modified Knee Society Score
timeFrame: 12 months
measure: Revisions/Removals
timeFrame: 3 years
measure: Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
timeFrame: 12 Months
measure: Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush University Medical Center
state: Illinois
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: