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Postoperative Function Following Partial and Total Knee Replacement

This study has been terminated.
(No longer have access to equipment used for functional data collection)
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by:
New Lexington Clinic
ClinicalTrials.gov Identifier:
NCT00492219
First received: June 25, 2007
Last updated: October 18, 2012
Last verified: June 2007
  Purpose

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.


Condition Intervention
Osteoarthritis
Post-traumatic Arthritis
Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses
Device: Total Knee Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Function Following Partial and Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by New Lexington Clinic:

Primary Outcome Measures:
  • Performance of three functional tests on a force platform [ Time Frame: Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative ] [ Designated as safety issue: No ]
  • Knee Society Scores [ Time Frame: Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery ] [ Designated as safety issue: No ]
  • Any postoperative complications [ Time Frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 324
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492219

Locations
United States, Kentucky
Lexington Clinic Sports Medicine Center
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
New Lexington Clinic
Biomet, Inc.
Investigators
Principal Investigator: Christian P Christensen, MD New Lexington Clinic
  More Information

Publications:
Responsible Party: Christian Christensen, MD, New Lexington Clinic, PSC
ClinicalTrials.gov Identifier: NCT00492219     History of Changes
Other Study ID Numbers: LCO.2006.05
Study First Received: June 25, 2007
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New Lexington Clinic:
arthroplasty
replacement
knee
prosthesis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014