Postoperative Function Following Partial and Total Knee Replacement

October 18, 2012 updated by: New Lexington Clinic
The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. The activities we are interested in include getting up out of a chair, stepping up and over a small wooden box, and standing still with the knees straight and also bent to 45 degrees.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be asked for a brief medical history so that we may determine if he/she can participate in the study. If the patient is going to have partial knee replacement, he/she will be randomly assigned to receive either a fixed-bearing (Vanguard M, Biomet, Warsaw, IN) or mobile-bearing (Oxford, Biomet, Warsaw, IN) partial knee replacement. Both implant systems are FDA approved and Dr. Christensen is equally skilled with both systems. The fixed-bearing partial knee replacement is made up of a polished metal piece that is cemented to the femur and a metal piece that is cemented to the tibia. The plastic portion of the fixed-bearing partial knee replacement is attached to the tibial metal tray and does not move. The mobile-bearing knee replacement also has a metal pieces cemented to the femur and tibia, but between the two metal pieces is a small plastic piece that moves as the knee bends and straightens. Patients will have an equal opportunity of receiving either implant system.

If the patient is having total knee replacement, the surgery will be the same as if he/she did not participate in the study, except that we will collect information from the patient during office visits and will ask the patient to perform the functional tests. If the participant is one of the healthy volunteers, he/she will not have knee surgery and will only be asked to perform the functional tests.

Information collected during office visits:

A member of our research team will ask the patient a series of questions about the knee. Patients will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten the knee at these 4 office visits. We will have patients rate the pain in their knee and ask if they are satisfied with the surgery. If patients have any complications, those will also be recorded. Patients will have X-rays taken of your knee at your follow-up visits. This is the normal routine following knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.

We will also ask patients to perform 3 functional tests at each of these office visits. These 3 tests will be performed on a raised platform that is approximately 2 inches above the floor. For the first test, the patient will be asked to stand still with knees straight for two seconds, and then be asked to stand still with knees bent to 45 degrees for two seconds. For the second test, the patient will be asked to stand up from a seated position. For the third test, the patient will be asked to step up onto a four-inch wooden box and then step back down onto the platform. Prior to testing, the patient will be allowed to practice each of these tests as many times as necessary until he/she feels comfortable. During testing, an investigator will help make sure that the patient is able to safely and properly perform 3 repetitions of each test. We will not ask patients to perform one or more of the functional tests if they are unable to perform the test without constant use of their arms for support.

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic Sports Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients that have elected to undergo either partial or total knee replacement, as well as a control group of patients free of lower extremity pathology

Exclusion Criteria:

  • Sensory, neurological, or general health conditions that alter perception of the patient's limb in space
  • Vestibular disorders will be excluded in order to protect against falls during functional testing
  • Unable to understand the questions used to obtain the Knee Society Score
  • Minors and prisoners will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients undergoing total knee replacement
Device: Total Knee Replacement
Patients undergoing total knee replacement with the Vanguard Complete Knee implant system
Other Names:
  • All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
No Intervention: 2
Healthy volunteers that are not undergoing knee replacement surgery
Experimental: 3
Patients undergoing partial knee replacement with the Oxford mobile bearing implant system
Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses
Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.
Other Names:
  • All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
Experimental: 4
Patients undergoing partial knee replacement with the Vanguard M implant system
Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses
Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.
Other Names:
  • All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance of three functional tests on a force platform
Time Frame: Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative
Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative
Knee Society Scores
Time Frame: Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Patient Satisfaction
Time Frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
6 weeks, 3 months, and 1, 2, and 5 years after surgery
Any postoperative complications
Time Frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
6 weeks, 3 months, and 1, 2, and 5 years after surgery
Radiographic signs of component loosening or change of position, as well as progression of arthritis in the lateral compartment for the partial knee replacement patients
Time Frame: 6 weeks and 1, 2, and 5 years postoperative
6 weeks and 1, 2, and 5 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Lexington Clinic

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Christian P Christensen, MD, New Lexington Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCO.2006.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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