A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Apr 2010
Longer than P75 for not_applicable knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 2, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 24, 2023
July 1, 2023
16.7 years
September 2, 2010
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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.
4 week
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.
1 year
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.
2 year
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.
5 year
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.
10 year
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.
15 year
Complications
The number and type of adverse events will be monitored to assess safety.
Date of surgery
Complications
The number and type of adverse events will be monitored to assess safety.
4 week
Complications
The number and type of adverse events will be monitored to assess safety.
4 month
Complications
The number and type of adverse events will be monitored to assess safety.
1 year
Complications
The number and type of adverse events will be monitored to assess safety.
2 year
Complications
The number and type of adverse events will be monitored to assess safety.
5 year
Complications
The number and type of adverse events will be monitored to assess safety.
10 year
Complications
The number and type of adverse events will be monitored to assess safety.
15 year
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.
4 month
Secondary Outcomes (14)
Knee Society Score
4 week
Knee Society Score
1 year
Knee Society Score
2 year
Knee Society Score
5 year
Knee Society Score
10 year
- +9 more secondary outcomes
Study Arms (2)
Cemented fixation
OTHERNexgen High-Flexion Knee Replacement System using Cemented Fixation
Cementless fixation
OTHERNexgen High-Flexion Knee Replacement System using Cementless Fixation
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis of osteoarthritis of the knee
- Patients undergoing primary total knee replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anderson Orthopaedic Research Institutelead
- Zimmer Biometcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin B Fricka, MD
Anderson Orthopaedic Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2010
First Posted
September 3, 2010
Study Start
April 1, 2010
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 24, 2023
Record last verified: 2023-07