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Active, Not Recruiting

NCT Number: NCT01194817

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Flexion Knee Replacement System using Cemented Fixation

Device

High-Flexion Knee Replacement System using Cementless Fixation

Device

Primary outcomes

  1. Radiographic analysis

    Time frame: 4 week

    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.

  2. Radiographic analysis

    Time frame: 1 year

    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.

  3. Radiographic analysis

    Time frame: 2 year

    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.

  4. Radiographic analysis

    Time frame: 5 year

    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.

  5. Radiographic analysis

    Time frame: 10 year

    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.

  6. Radiographic analysis

    Time frame: 15 year

    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.

  7. Complications

    Time frame: Date of surgery

    The number and type of adverse events will be monitored to assess safety.

  8. Complications

    Time frame: 4 week

    The number and type of adverse events will be monitored to assess safety.

  9. Complications

    Time frame: 4 month

    The number and type of adverse events will be monitored to assess safety.

  10. Complications

    Time frame: 1 year

    The number and type of adverse events will be monitored to assess safety.

  11. Complications

    Time frame: 2 year

    The number and type of adverse events will be monitored to assess safety.

  12. Complications

    Time frame: 5 year

    The number and type of adverse events will be monitored to assess safety.

  13. Complications

    Time frame: 10 year

    The number and type of adverse events will be monitored to assess safety.

  14. Complications

    Time frame: 15 year

    The number and type of adverse events will be monitored to assess safety.

  15. Radiographic analysis

    Time frame: 4 month

    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 outcomes

  1. Knee Society Score

    Time frame: 4 week

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  2. Knee Society Score

    Time frame: 1 year

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  3. Knee Society Score

    Time frame: 2 year

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  4. Knee Society Score

    Time frame: 5 year

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  5. Knee Society Score

    Time frame: 10 year

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  6. Knee Society Score

    Time frame: 15 year

    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  7. Oxford Knee Score

    Time frame: 4 week

    A patient reported questionnaire for assessing the outcome of knee surgery.

  8. Oxford Knee Score

    Time frame: 1 year

    A patient reported questionnaire for assessing the outcome of knee surgery.

  9. Oxford Knee Score

    Time frame: 2 year

    A patient reported questionnaire for assessing the outcome of knee surgery.

  10. Oxford Knee Score

    Time frame: 5 year

    A patient reported questionnaire for assessing the outcome of knee surgery.

  11. Oxford Knee Score

    Time frame: 10 year

    A patient reported questionnaire for assessing the outcome of knee surgery.

  12. Oxford Knee Score

    Time frame: 15 year

    A patient reported questionnaire for assessing the outcome of knee surgery.

  13. Visual analog pain score

    Time frame: 4 week

    Pain score will be measured from a patient-assessed visual analog pain scale.

  14. Visual analog pain score

    Time frame: 4 month

    Pain score will be measured from a patient-assessed visual analog pain scale.

Sponsors and collaborators

Lead sponsor

Anderson Orthopaedic Research Institute

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2010
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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