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

Osteoarthritis of the Knee Clinical Trial

— Cutting Block  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072019
• Other study ID #: 10-0018
• Secondary ID: Ortho.CR.K018.10
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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