RCT Vanguard XP

Principal Investigator: Jeremy Gililland
Keywords: Total Knee Arthroplasty , Bicruciate Sparing TKA , Outcomes , Biomet Vanguard XP , Biomet Vanguard CR Department: Orthopedic Surgery
IRB Number: 00072053 Co Investigator: Christopher Peters
Specialty: Orthopaedic Surgery
Sub Specialties: Adult Reconstruction
Recruitment Status: Enrolling by invitation

Contact Information

Michael Anderson

Brief Summary

The Objectives of this study include: 

  1. Compare patient perception of their knee implant feeling “normal / asymptomatic.”
  2. Compare clinical outcomes through 2 year standard of care follow-up.
  3. Evaluate patient perceived clinical outcomes and survivorship through 10-years of follow-up.

Inclusion Criteria

Subjects will be considered for inclusion in this trial if they satisfy the following study criteria* and FDA cleared indications for use: 

A. Cemented application of components 

B. Bilateral subjects randomized by knee

C. Patients with pre-existing contralateral knee surgery

D. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis or traumatic arthritis where one or more compartments are involved. 

E. Correction of varus, valgus, or posttraumatic deformity 

F. Sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament. 


Exclusion Criteria

Subjects should be excluded from this trial if they satisfy any of the following study criteria* and contraindications for the device: 

A. Cementless application of components

B. BMI ≥40 kg/m2 * 

C. Use of Anterior Stabilized Bearings

D. Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees

E. Correction or revision of previous joint replacement procedure on index knee

F. Infection 

G. Sepsis 

H. Osteomyelitis 


Relative contraindications include: 

I. Uncooperative patient or patient with neurologic disorders who is incapable of following directions 

J. Osteoporosis 

K. Metabolic disorders which may impair bone formation, 

L. Osteomalacia 

M. Distant foci of infections which may spread to the implant site 

N. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram 

O. Vascular insufficiency, muscular atrophy, neuromuscular disease 

P. Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament.