Knee OsteoarthritisNCT01194817
A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement
A study testing High-Flexion Knee Replacement System using Cemented Fixation and High-Flexion Knee Replacement System using Cementless Fixation in people with Knee Osteoarthritis, run by Anderson Orthopaedic Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High-Flexion Knee Replacement System using Cemented Fixation and High-Flexion Knee Replacement System using Cementless Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary diagnosis of osteoarthritis of the knee
- Patients undergoing primary total knee replacement
Who cannot join
- 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
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- High-Flexion Knee Replacement System using Cemented Fixation, High-Flexion Knee Replacement System using Cementless Fixation
- Keywords
- total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flexion Knee Replacement System using Cemented FixationDevice
High-Flexion Knee Replacement System using Cementless FixationDevice
| Study group | Role | What they receive |
|---|---|---|
| Cemented fixation | Other | Nexgen High-Flexion Knee Replacement System using Cemented Fixation Receives: Device: High-Flexion Knee Replacement System using Cemented Fixation |
| Cementless fixation | Other | Nexgen High-Flexion Knee Replacement System using Cementless Fixation Receives: Device: High-Flexion Knee Replacement System using Cementless Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 year
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: Date of surgery
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 4 week
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 4 month
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 1 year
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 2 year
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 5 year
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 10 year
Complications
The number and type of adverse events will be monitored to assess safety.
Measured: 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.
Measured: 4 month
Secondary outcomes (14)
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 4 week
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 1 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 2 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 5 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 10 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Measured: 15 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 4 week
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 1 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 2 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 5 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 10 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Measured: 15 year
Visual analog pain score
Pain score will be measured from a patient-assessed visual analog pain scale.
Measured: 4 week
Visual analog pain score
Pain score will be measured from a patient-assessed visual analog pain scale.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Kevin B. Fricka, MD, Anderson Orthopaedic Research Institute
- Investigators
- Kevin B Fricka, MD, Principal investigator, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194817
- Sponsor's protocol ID
- AORI2010-0105
- Status last verified
- Jul 2023
- First submitted
- 2 Sep 2010
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01194817
- Acronym / sponsor ID
- AORI2010-0105
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Apr 2010
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented fixation | Other | Device: High-Flexion Knee Replacement System using Cemented FixationNexgen High-Flexion Knee Replacement System using Cemented Fixation |
| Cementless fixation | Other | Device: High-Flexion Knee Replacement System using Cementless FixationNexgen High-Flexion Knee Replacement System using Cementless Fixation |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of osteoarthritis of the knee
- Patients undergoing primary total knee replacement
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Flexion Knee Replacement System using Cemented Fixation | Device | Cemented fixation |
| High-Flexion Knee Replacement System using Cementless Fixation | Device | Cementless fixation |
Primary outcome
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.
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.
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.
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.
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.
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.
Complications
Time frame: Date of surgery
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 4 week
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 4 month
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 1 year
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 2 year
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 5 year
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 10 year
The number and type of adverse events will be monitored to assess safety.
Complications
Time frame: 15 year
The number and type of adverse events will be monitored to assess safety.
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.
14 secondary outcomes
Knee Society Score
Time frame: 4 week
Knee Society Score
Time frame: 1 year
Knee Society Score
Time frame: 2 year
Knee Society Score
Time frame: 5 year
Knee Society Score
Time frame: 10 year
Knee Society Score
Time frame: 15 year
Oxford Knee Score
Time frame: 4 week
Oxford Knee Score
Time frame: 1 year
Oxford Knee Score
Time frame: 2 year
Oxford Knee Score
Time frame: 5 year
Oxford Knee Score
Time frame: 10 year
Oxford Knee Score
Time frame: 15 year
Visual analog pain score
Time frame: 4 week
Visual analog pain score
Time frame: 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin B Fricka, MD principal investigator
Anderson Orthopaedic Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing High-Flexion Knee Replacement System using Cemented Fixation and High-Flexion Knee Replacement System using Cementless Fixation in people with Knee Osteoarthritis, run by Anderson Orthopaedic Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic analysis (time frame: 4 week). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.