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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Kevin Fricka, MD, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01194817
First received: September 2, 2010
Last updated: February 1, 2013
Last verified: February 2013

September 2, 2010
February 1, 2013
April 2010
December 2026   (final data collection date for primary outcome measure)
  • Radiographic analysis [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 15 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Date of surgery ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 10 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Complications [ Time Frame: 15 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.
  • Radiographic analysis [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01194817 on ClinicalTrials.gov Archive Site
  • Knee Society Score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Knee Society Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Knee Society Score [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Knee Society Score [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Knee Society Score [ Time Frame: 15 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
  • Oxford Knee Score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Oxford Knee Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Oxford Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Oxford Knee Score [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Oxford Knee Score [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Oxford Knee Score [ Time Frame: 15 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.
  • Visual analog pain score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    Pain score will be measured from a patient-assessed visual analog pain scale.
  • Visual analog pain score [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Pain score will be measured from a patient-assessed visual analog pain scale.
Same as current
Not Provided
Not Provided
 
A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement
A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
  • Device: High-Flexion Knee Replacement System using Cemented Fixation
  • Device: High-Flexion Knee Replacement System using Cementless Fixation
  • Cemented fixation
    Nexgen High-Flexion Knee Replacement System using Cemented Fixation
    Intervention: Device: High-Flexion Knee Replacement System using Cemented Fixation
  • Cementless fixation
    Nexgen High-Flexion Knee Replacement System using Cementless Fixation
    Intervention: Device: High-Flexion Knee Replacement System using Cementless Fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2026
December 2026   (final data collection date for primary outcome measure)

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
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01194817
AORI2010-0105
No
Kevin Fricka, MD, Anderson Orthopaedic Research Institute
Anderson Orthopaedic Research Institute
Zimmer, Inc.
Principal Investigator: Kevin B Fricka, MD Anderson Orthopaedic Research Institute
Anderson Orthopaedic Research Institute
February 2013

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