NCT01072019

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

4.2 years

First QC Date

February 18, 2010

Last Update Submit

June 25, 2018

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Patient dissatisfaction following primary total knee replacement.

    Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.

Secondary Outcomes (1)

  • 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.

Study Arms (2)

Standard knee cutting guides

ACTIVE COMPARATOR

Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.

Other: Instrument

MRI generated patient specific custom cutting guides

ACTIVE COMPARATOR

Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.

Other: Instrument

Interventions

InstrumentOTHER

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

Also known as: Vanguard® Knee System, Signature™ Custom Guides
MRI generated patient specific custom cutting guidesStandard knee cutting guides

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ryan M Nunley, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

US(1)