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A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-Flexion Knee Replacement System using Cemented Fixation
High-Flexion Knee Replacement System using Cementless Fixation
Sponsored by
Anderson Orthopaedic Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary diagnosis of osteoarthritis of the knee
  • Patients undergoing primary total knee replacement

Exclusion Criteria:

  • Age over 75 years old
  • Prior unicondylar knee arthroplasty
  • Grossly porotic bone or bone defects requiring bone grafting
  • Bone cuts not sufficiently accurate for cementless fixation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Cemented fixation

    Cementless fixation

    Arm Description

    Nexgen High-Flexion Knee Replacement System using Cemented Fixation

    Nexgen High-Flexion Knee Replacement System using Cementless Fixation

    Outcomes

    Primary Outcome Measures

    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Complications
    The number and type of adverse events will be monitored to assess safety.
    Radiographic analysis
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.

    Secondary Outcome Measures

    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Knee Society Score
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Oxford Knee Score
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Visual analog pain score
    Pain score will be measured from a patient-assessed visual analog pain scale.
    Visual analog pain score
    Pain score will be measured from a patient-assessed visual analog pain scale.

    Full Information

    First Posted
    September 2, 2010
    Last Updated
    July 20, 2023
    Sponsor
    Anderson Orthopaedic Research Institute
    Collaborators
    Zimmer Biomet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01194817
    Brief Title
    A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement
    Official Title
    A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Anderson Orthopaedic Research Institute
    Collaborators
    Zimmer Biomet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cemented fixation
    Arm Type
    Other
    Arm Description
    Nexgen High-Flexion Knee Replacement System using Cemented Fixation
    Arm Title
    Cementless fixation
    Arm Type
    Other
    Arm Description
    Nexgen High-Flexion Knee Replacement System using Cementless Fixation
    Intervention Type
    Device
    Intervention Name(s)
    High-Flexion Knee Replacement System using Cemented Fixation
    Intervention Type
    Device
    Intervention Name(s)
    High-Flexion Knee Replacement System using Cementless Fixation
    Primary Outcome Measure Information:
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    4 week
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    1 year
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    2 year
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    5 year
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    10 year
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    15 year
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    Date of surgery
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    4 week
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    4 month
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    1 year
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    2 year
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    5 year
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    10 year
    Title
    Complications
    Description
    The number and type of adverse events will be monitored to assess safety.
    Time Frame
    15 year
    Title
    Radiographic analysis
    Description
    Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
    Time Frame
    4 month
    Secondary Outcome Measure Information:
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    4 week
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    1 year
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    2 year
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    5 year
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    10 year
    Title
    Knee Society Score
    Description
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
    Time Frame
    15 year
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    4 week
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    1 year
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    2 year
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    5 year
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    10 year
    Title
    Oxford Knee Score
    Description
    A patient reported questionnaire for assessing the outcome of knee surgery.
    Time Frame
    15 year
    Title
    Visual analog pain score
    Description
    Pain score will be measured from a patient-assessed visual analog pain scale.
    Time Frame
    4 week
    Title
    Visual analog pain score
    Description
    Pain score will be measured from a patient-assessed visual analog pain scale.
    Time Frame
    4 month

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary diagnosis of osteoarthritis of the knee Patients undergoing primary total knee replacement Exclusion Criteria: Age over 75 years old Prior unicondylar knee arthroplasty Grossly porotic bone or bone defects requiring bone grafting Bone cuts not sufficiently accurate for cementless fixation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin B Fricka, MD
    Organizational Affiliation
    Anderson Orthopaedic Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

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