Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomechanical Assessment of a High Congruency Knee Bearing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422251
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
University of Strathclyde
Information provided by (Responsible Party):
Golden Jubilee National Hospital

Brief Summary:

The aim of the project is to compare the biomechanics of three different bearing designs used in total knee replacement (TKR) implants. The bearing is the part in the middle of the knee implant that allows the metal tray attached to the shin bone (tibia) to move in relation to the metal part attached to the thigh bone (femur) and is usually made of plastic (high density polyethylene). There will be three different bearing types in the study, which all give different movements. This study will see which bearing is most like a natural knee and so which design gives the best function and feeling to patients with a TKR. 90 TKR patients from the Golden Jubilee National Hospital will be recruited and randomised to receive one of the three study bearings (30 in each group). In addition, a control group of 30 healthy individuals of similar age will be recruited for comparison. Before surgery and at 4 to 8 weeks and 1 year after their operation patients will attend biomechanical assessment sessions at the University of Strathclyde. The control group will attend the assessment session only once. In each of these sessions they will carry out a number of everyday tasks such as walking, moving from sitting to standing and going up and down stairs. These tasks will be measured using motion capture techniques. Reflective markers placed on each participant will be tracked by cameras so that their movements can be recorded. Force plates in the floor will record the forces during the tasks.

Movement and force data will be analysed to see if any differences exist between the groups and show which bearing gives the most natural movement.


Condition or disease Intervention/treatment Phase
Knee Replacement Device: Mobile high congruency bearing (Columbus) Device: Fixed high congruency bearing (Columbus) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Investigation of the Functional Outcomes of High Congruency Versus Low Congruency Knee Bearings
Actual Study Start Date : August 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Mobile high congruency bearing
Device B Braun Columbus total knee system using a rotating platform tibia and high congruency mobile bearing.
Device: Mobile high congruency bearing (Columbus)
Columbus high congruency bearing on a rotating platform tibia.

Experimental: Fixed high congruency bearing
Device B Braun Columbus total knee system using a fixed tibial platform and high congruency bearing.
Device: Fixed high congruency bearing (Columbus)
Columbus high congruency bearing on a fixed platform tibia.

Experimental: Fixed low congruency bearing
Device B Braun Columbus total knee system using a fixed tibial platform and low congruency bearing.
Device: Fixed high congruency bearing (Columbus)
Columbus deep dish bearing on a fixed platform tibia.

No Intervention: Control
Healthy control group



Primary Outcome Measures :
  1. Knee kinematics [ Time Frame: 1 year ]
    Knee range of motion during activities of daily living


Secondary Outcome Measures :
  1. Hip kinematics [ Time Frame: 1 year ]
    Hip range of motion during activities of daily living

  2. Hip kinetics [ Time Frame: 1 year ]
    Hip loading during activities of daily living

  3. Knee kinetics [ Time Frame: 1 year ]
    Knee loading during activities of daily living

  4. Ankle kinematics [ Time Frame: 1 year ]
    Ankle range of motion during activities of daily living

  5. Ankle kinetics [ Time Frame: 1 year ]
    Ankle loading during activities of daily living

  6. EQ-5D [ Time Frame: 1 year ]
    EQ-5D health questionnaire score

  7. Oxford Knee Score [ Time Frame: 1 year ]
    Oxford Knee Score questionnaire score

  8. Knee alignment [ Time Frame: 1 year ]
    Frontal plane alignment of the knee

  9. Patient satisfaction [ Time Frame: 1 year ]
    Score of patients' satisfaction with the implant

  10. Complications [ Time Frame: 1 year ]
    Evidence of any complication related to the surgery



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Primary unilateral total knee replacement
  2. Suitable to have any one of the three test bearings
  3. Over 35 years of age
  4. Willing to take part
  5. From one of the following NHS Scotland Health Boards: Ayrshire & Arran, Forth Valley, Greater Glasgow & Clyde, Highland, Lanarkshire or Lothian
  6. Able to return for follow up sessions

Exclusion Criteria:

  1. Previous hip or knee replacement procedure if carried out in the previous twelve months
  2. Unable to give written consent
  3. Unable to attend the movement analysis sessions
  4. Journey time from home to the university in excess of two hours
  5. Previous ankle surgery
  6. Any past neurologic history e.g. stroke, Charcot-Marie-Tooth disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422251


Locations
Layout table for location information
United Kingdom
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, United Kingdom, G81 4dy
Sponsors and Collaborators
Golden Jubilee National Hospital
University of Strathclyde
Investigators
Layout table for investigator information
Principal Investigator: Frederic Picard, MD National Waiting Times Centre

Layout table for additonal information
Responsible Party: Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT02422251     History of Changes
Other Study ID Numbers: Ortho 14-12
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019