Postoperative Function Following Partial and Total Knee Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by New Lexington Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by:
New Lexington Clinic
ClinicalTrials.gov Identifier:
NCT00492219
First received: June 25, 2007
Last updated: June 26, 2007
Last verified: June 2007

June 25, 2007
June 26, 2007
October 2006
 
  • Performance of three functional tests on a force platform [ Time Frame: Baseline (preoperative), 6 weeks, 3 months, and 1 year postoperative ]
  • Knee Society Scores [ Time Frame: Baseline (preoperative), and 6 weeks, 3 months, and one year after surgery ]
  • Patient Satisfaction [ Time Frame: 6 weeks, 3 months, and one year after surgery ]
  • Any postoperative complications [ Time Frame: 6 weeks, 3 months, and one year after surgery ]
Same as current
Complete list of historical versions of study NCT00492219 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Postoperative Function Following Partial and Total Knee Replacement
Postoperative Function Following Partial and Total Knee Replacement

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.

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.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Post-Traumatic Arthritis
Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
October 2009
 

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
Both
18 Years and older
Yes
Contact: Cale A Jacobs, PhD (859) 258-8560 cjaco@lexclin.com
United States
 
NCT00492219
LCO.2006.05
No
 
New Lexington Clinic
Biomet, Inc.
Principal Investigator: Cale A Jacobs, PhD New Lexington Clinic
Principal Investigator: Christian P Christensen, MD New Lexington Clinic
New Lexington Clinic
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP