A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides

Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072019

Acronym

Cutting Block

Enrollment

Registered

2010-02-19

Start date

2010-03-31

Completion date

2014-05-31

Last updated

2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

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.

Interventions

OTHERInstrument

Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Patient dissatisfaction following primary total knee replacement.	Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.

Secondary

Measure	Time frame
Postoperative recovery time following primary total knee replacement.	Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026