Total Knee ArthroplastyNCT03731676
Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
A study testing Fixed bearing total knee arthroplasty and Rotating platform total knee arthroplasty in people with Total Knee Arthroplasty, run by William Hopkinson at 1 site in United States.
Trial summary
Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Fixed bearing total knee arthroplasty and Rotating platform total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2000to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Osteoarthritis
- Rheumatoid or other inflammatory arthritis
- Post-traumatic arthritis
- Juvenile rheumatoid arthritis
- Avascular necrosis
Who cannot join
- History of recent/active joint sepsis
- Charcot neuropathy
- Psycho-social disorders that would limit rehabilitation
- Metabolic disorders of calcified tissues, such as Paget's disease
- Joint replacement due to autoimmune disorders
- Skeletal immaturity
- Ligamentous laxity requiring a constrained prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Fixed bearing total knee arthroplasty, Rotating platform total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed bearing total knee arthroplastyDevice
Fixed bearing total knee arthroplasty
Rotating platform total knee arthroplastyDevice
Rotating platform total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Rotating platform total knee arthroplasty | Active comparator | These patients were randomly assigned to receive a rotating platform total knee arthroplasty. Receives: Device: Rotating platform total knee arthroplasty |
| Fixed bearing total knee arthroplasty | Active comparator | These patients were randomly assigned to receive a fixed bearing total knee arthroplasty. Receives: Device: Fixed bearing total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Status over time
Knee Society Clinical Rating Scale
Measured: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Change in Osteoarthritis Status over time
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items)
Measured: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Change in Overall Health Status over time
Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health.
Measured: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Secondary outcomes (1)
Change in Satisfaction of Knee over time
4-point Likert scale used to assess satisfaction with knee Scale-1. Extremely satisfied 2. Satisfied 3. Unsatisfied 4. Extremely unsatisfied
Measured: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Dec 2000
- Primary completion31 Dec 2001
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Hopkinson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William Hopkinson, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731676
- Sponsor's protocol ID
- 11119
- Status last verified
- Apr 2021
- First submitted
- 16 Oct 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results in a general basis via a manuscript. No individual data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03731676
- Acronym / sponsor ID
- 11119
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- William HopkinsonUniversity, hospital or other
- Study start
- 1 Dec 2000 (actual)
- Primary completion
- 31 Dec 2001 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Nov 2018 (actual)
- 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.
Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotating platform total knee arthroplasty | Active comparator | Device: Rotating platform total knee arthroplastyThese patients were randomly assigned to receive a rotating platform total knee arthroplasty. |
| Fixed bearing total knee arthroplasty | Active comparator | Device: Fixed bearing total knee arthroplastyThese patients were randomly assigned to receive a fixed bearing total knee arthroplasty. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Osteoarthritis
- Rheumatoid or other inflammatory arthritis
- Post-traumatic arthritis
- Juvenile rheumatoid arthritis
- Avascular necrosis
Key exclusion criteria (7 listed)
- History of recent/active joint sepsis
- Charcot neuropathy
- Psycho-social disorders that would limit rehabilitation
- Metabolic disorders of calcified tissues, such as Paget's disease
- Joint replacement due to autoimmune disorders
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 |
|---|---|---|
| Fixed bearing total knee arthroplastyFixed bearing total knee arthroplasty | Device | Fixed bearing total knee arthroplasty |
| Rotating platform total knee arthroplastyRotating platform total knee arthroplasty | Device | Rotating platform total knee arthroplasty |
Primary outcome
Change in Functional Status over time
Time frame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Knee Society Clinical Rating Scale
Change in Osteoarthritis Status over time
Time frame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items)
Change in Overall Health Status over time
Time frame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health.
1 secondary outcome
Change in Satisfaction of Knee over time
Time frame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No. Results in a general basis via a manuscript. No individual data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed bearing total knee arthroplasty and Rotating platform total knee arthroplasty in people with Total Knee Arthroplasty, run by William Hopkinson at 1 site in United States.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Change in Functional Status over time (time frame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.). 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 19 Apr 2021.