Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Rheumatoid Arthritis Clinical Trial

— GK9B  

Official title:

Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02175576
• Other study ID #: ORTHO.CR.GK9B
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: February 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Vanguard XP Bicruciate Knee System
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
• Vanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.

Locations

Country	Name	City	State
United States	Midwest Orthopaedics at Rush University Medical Center	Chicago	Illinois
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Revisions/Removals	Number of study device revisions or removals reported during the study.	3 years
Secondary	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
Secondary	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