Clinical trial NCT01072019: A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides
Official title: Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2010-02-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:

1. Standard knee cutting guides;
2. MRI generated patient specific custom cutting guides.

Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 75
* Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
* Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
* Correction of varus or valgus.
* Willing to participate and return for follow-up study visits.

Exclusion Criteria:

* Infection
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic 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
* Previous osteotomy
* Diagnosis of rheumatoid arthritis
* Previous patella fracture or surgery
* Previous healed tibia or femur fractures
* Previous joint replacement surgery
* Cannot have an MRI
* Patients receiving single-stage bilateral total knee arthroplasty (TKA)

Primary outcomes:
measure: Patient dissatisfaction following primary total knee replacement.
timeFrame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.
Secondary outcomes:
measure: Postoperative recovery time following primary total knee replacement.
timeFrame: Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan M Nunley, MD
role: PRINCIPAL_INVESTIGATOR
References: