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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
History of Changes
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
 Device: High-Flexion Knee Replacement System using Cemented Fixation
Device: High-Flexion Knee Replacement System using Cementless Fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cemented fixation
Nexgen High-Flexion Knee Replacement System using Cemented Fixation
 Device: High-Flexion Knee Replacement System using Cemented Fixation
Cementless fixation
Nexgen High-Flexion Knee Replacement System using Cementless Fixation
 Device: High-Flexion Knee Replacement System using Cementless Fixation

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194817

Sponsors and Collaborators
Anderson Orthopaedic Research Institute
Zimmer, Inc.
Investigators
Principal Investigator: Kevin B Fricka, MD Anderson Orthopaedic Research Institute
  More Information

No publications provided

Responsible Party: Kevin Fricka, MD, Principal Investigator, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01194817     History of Changes
Other Study ID Numbers: AORI2010-0105
Study First Received: September 2, 2010
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
total knee arthroplasty
total knee replacement
cementless TKA
high flexion
trabecular metal

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

ClinicalTrials.gov processed this record on May 23, 2013