Knee OsteoarthritisNCT01176292
Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
A study testing Rotating Platform High-Flex Cruciate Substituting TKA and Rotating Platform Cruciate Substituting TKA in people with Knee Osteoarthritis, run by Anderson Orthopaedic Research Institute.
Trial summary
The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Rotating Platform High-Flex Cruciate Substituting TKA and Rotating Platform Cruciate Substituting TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 75 years old
- Primary diagnosis of osteoarthritis of the knee
- Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
- Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.
Who cannot join
- Pregnant or lactating female subjects
- Patients with post-traumatic or inflammatory arthritis
- Patients with a fixed flexion contracture of greater than 20 degrees
- Patients with advanced hip, spine, or ankle disease
- Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues
About this study
Official title: A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Rotating Platform High-Flex Cruciate Substituting TKA, Rotating Platform Cruciate Substituting TKA
- Keywords
- total knee replacement, high flexion, range of motion, rotating platform, TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotating Platform High-Flex Cruciate Substituting TKADevice
Rotating Platform Cruciate Substituting TKADevice
| Study group | Role | What they receive |
|---|---|---|
| Rotating Platform High-Flex Cruciate Substituting TKA | Other | Not described Receives: Device: Rotating Platform High-Flex Cruciate Substituting TKA |
| Rotating Platform Cruciate Substituting TKA | Other | Not described Receives: Device: Rotating Platform Cruciate Substituting TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: Preoperative, 4-6 weeks
Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: 4-6 months
Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: 1 year
Secondary outcomes (4)
Radiographic Flexion
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Measured: preoperative, 4-6 weeks
Radiographic Flexion
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Measured: 1 year
Knee Society Score (KSS)
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.
Measured: 1 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, William G. Hamilton, MD, Anderson Orthopaedic Research Institute
- Investigators
- William G Hamilton, MD, Principal investigator, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176292
- Sponsor's protocol ID
- AORI2010-0104
- Status last verified
- Nov 2020
- First submitted
- 26 Jul 2010
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01176292
- Acronym / sponsor ID
- AORI2010-0104
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee replacement, high flexion, range of motion, rotating platform, TKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Aug 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotating Platform High-Flex Cruciate Substituting TKA | Other | Device: Rotating Platform High-Flex Cruciate Substituting TKA |
| Rotating Platform Cruciate Substituting TKA | Other | Device: Rotating Platform Cruciate Substituting TKA |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 to 75 years old
- Primary diagnosis of osteoarthritis of the knee
- Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
- Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.
Key exclusion criteria (5 listed)
- Pregnant or lactating female subjects
- Patients with post-traumatic or inflammatory arthritis
- Patients with a fixed flexion contracture of greater than 20 degrees
- Patients with advanced hip, spine, or ankle disease
- Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues
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 |
|---|---|---|
| Rotating Platform High-Flex Cruciate Substituting TKA | Device | Rotating Platform High-Flex Cruciate Substituting TKA |
| Rotating Platform Cruciate Substituting TKA | Device | Rotating Platform Cruciate Substituting TKA |
Primary outcome
Clinical Flexion
Time frame: Preoperative, 4-6 weeks
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
Time frame: 4-6 months
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
Time frame: 1 year
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
4 secondary outcomes
Radiographic Flexion
Time frame: preoperative, 4-6 weeks
Radiographic Flexion
Time frame: 1 year
Knee Society Score (KSS)
Time frame: 1 year
Oxford Knee Score
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William G Hamilton, MD principal investigator
Anderson Orthopaedic Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Rotating Platform High-Flex Cruciate Substituting TKA and Rotating Platform Cruciate Substituting TKA 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Flexion (time frame: Preoperative, 4-6 weeks). The study lists 3 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 23 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.