Osteoarthritis, KneeNCT03569670
All-Polyethylene Tibias in TKA: PS vs CS Implants
A study testing Posterior stabilized all-polyethylene tibial component and Cruciate retaining all-polyethylene tibial component in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Posterior stabilized all-polyethylene tibial component and Cruciate retaining all-polyethylene tibial component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2020to Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis
- primary total knee arthroplasty
- able to consent for themself
Who cannot join
- inflammatory arthropathy
- fibromyalgia
- chronic pain syndrome
- previous distal femur or proximal tibia open reduction internal fixation
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
About this study
Official title: All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants
This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). We will use radiostereometric analysis to assess the stability of the implants at 6 weeks, 3 months, 6 months, 1 year and 2 year post-operatively. The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient BMI significantly impacts the stability of AP tibial components.
Read the detailed description
With healthcare expenditures rising as our population ages, there have been significant efforts targeted towards streamlining costs associated with various medical treatments. One area of substantial spending in the orthopaedic surgery field is total joint replacements. The effort to reduce costs has sparked a renewed interest in the use of allpolyethylene (AP) tibial components in total knee arthroplasty (TKA).
In recent years, there has been ample research demonstrating that AP tibial components have performed as good as, or better, than metal-backed (MB) tibial components. Some studies have estimated that cost savings could be as high as 50% with routine use of AP tibial components. While sufficient literature exists demonstrating the equivalence or superiority of AP versus MB designs, there is a paucity of work done comparing different types of AP tibial components.
Tibial components in TKA can be of the posterior stabilizing (PS) or cruciate retaining (CR) variety. To date, we are unaware of any study that directly compares AP tibial PS components to AP tibial CR components.
Radiostereometric analysis (RSA) has evolved as an exceptionally precise and reliable method for assessing the migration of components in total joint arthroplasty. Using RSA data, it is possible to accurately predict, within the first 24 months post-operatively, the survival of a total joint arthroplasty. Furthermore, the use of RSA outcomes in arthroplasty research allows for adequately powered studies with significantly smaller sample sizes than previously required.
The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient body mass index (BMI) significantly impacts the stability of AP tibial components.
We will prospectively enroll patients who will be undergoing a total knee arthroplasty by one of the study investigators. Potentially eligible patients will have the project explained to them during their preadmission clinic visit prior to surgery and if interested a member of the research team will perform the informed consent process. Should a patient elect to participate in the study they will sign the informed consent form and complete demographics and baseline health related quality of life questionnaires including Oxford Knee, EQ-5D, and the VR-12, in addition to the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) which is already completed as per standard of care. The baseline demographic characteristics that will be collected include age, BMI, gender, and relevant medical comorbidities. Patients will be randomized to have either a PS or CR all-poly tibial component used during surgery. Randomization will be stratified by BMI to ensure equal distribution in both groups.
During surgery the surgeon will insert 6-9 tantalum beads in the proximal tibial, 6 beads in the polyeythylene tray, and another bead into the tip of the polyethylene stem. These beads will be used to measure migration of the implants on RSA imaging (radiostereometric analysis).
The RSA x-rays will be taken at baseline (2 weeks) and at the 6-week, 3 months, 6 months and 1 year and 2 year follow-up appointments. These images will be taken at Robarts Research Institute in the RSA analysis suite. At the 3month, 6 month, 1 year and 2 year visits we will also collect health related quality of life questionnaires including the WOMAC, Oxford Knee, EQ-5D and the VR-12.
Patients and data collector will be blinded to treatment arm. The person who will analyze the RSA images will be able to see which treatment arm participants belong to (based on viewing xrays) however the hypothesis of the study will not be revealed to them prior to analysis.
Intra-operative cost information will also be collected using institutional cost data in order to compare differences in OR costs between the two implant designs and across BMI categories.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Posterior stabilized all-polyethylene tibial component, Cruciate retaining all-polyethylene tibial component
- Keywords
- cost, total knee replacement, arthroplasty, posterior stabilized, cruciate retaining, all-polyethylene
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior stabilized all-polyethylene tibial componentDevice
Patients randomized to this arm will have a Triathlon implant with a posterior stabilized, all-polyethylene tibial component used during surgery.
Cruciate retaining all-polyethylene tibial componentDevice
Patients randomized to this arm will have a Triathlon implant with a cruciate retaining, all-polyethylene tibial component used during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Stabilized | Experimental | A posterior stabilized, all-polyethylene tibial component will be used during surgery. Receives: Device: Posterior stabilized all-polyethylene tibial component |
| Cruciate Retaining | Active comparator | A cruciate retaining, all-polyethylene tibial component will be used during surgery. Receives: Device: Cruciate retaining all-polyethylene tibial component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Migration
Comparison of the two component types using radiostereometric analysis imaging.
Measured: Change between baseline (taken at 2 weeks post-operatively) and 2 years
Secondary outcomes (5)
VR-12
Patient-reported outcome used to assess general health.
Measured: 2 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Patient-reported outcome used to assess function, pain and stiffness.
Measured: 2 years
Oxford Knee Score
Patient-reported outcome used to assess knee function.
Measured: 2 years
EQ-5D
Patient-reported outcome used to assess quality of life.
Measured: 2 years
Cost
Intraoperative costs will be collected using institutional cost data.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startJan 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Study has been suspended due to inability to obtain funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Edward Vasarhelyi, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569670
- Sponsor's protocol ID
- 110812
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gioe TJ, Maheshwari AV. The all-polyethylene tibial component in primary total knee arthroplasty. J Bone Joint Surg Am. 2010 Feb;92(2):478-87. doi: 10.2106/JBJS.I.00842.
PubMed 20124081Medel F, Kurtz SM, Klein G, Levine H, Sharkey P, Austin M, Kraay M, Rimnac CM. Clinical, surface damage and oxidative performance of poly II tibial inserts after long-term implantation. J Long Term Eff Med Implants. 2008;18(2):151-65. doi: 10.1615/jlongtermeffmedimplants.v18.i2.40.
PubMed 19968624Adalberth G, Nilsson KG, Bystrom S, Kolstad K, Milbrink J. Low-conforming all-polyethylene tibial component not inferior to metal-backed component in cemented total knee arthroplasty: prospective, randomized radiostereometric analysis study of the AGC total knee prosthesis. J Arthroplasty. 2000 Sep;15(6):783-92. doi: 10.1054/arth.2000.8101.
PubMed 11021456Yassin M, Garti A, Weissbrot M, Ashkenazi U, Khatib M, Robinson D. All-polyethylene tibial components are not inferior to metal-backed tibial components in long-term follow-up of knee arthroplasties. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1087-91. doi: 10.1007/s00590-015-1645-y. Epub 2015 May 26.
PubMed 26006786Norgren B, Dalen T, Nilsson KG. All-poly tibial component better than metal-backed: a randomized RSA study. Knee. 2004 Jun;11(3):189-96. doi: 10.1016/S0968-0160(03)00071-1.
PubMed 15194094Nouta KA, Verra WC, Pijls BG, Schoones JW, Nelissen RG. All-polyethylene tibial components are equal to metal-backed components: systematic review and meta-regression. Clin Orthop Relat Res. 2012 Dec;470(12):3549-59. doi: 10.1007/s11999-012-2582-2. Epub 2012 Sep 13.
PubMed 22972656Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
PubMed 16195075
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants
- ClinicalTrials.gov ID
- NCT03569670
- Acronym / sponsor ID
- 110812
- Conditions
- Osteoarthritis, Knee
- Keywords
- cost, total knee replacement, arthroplasty, posterior stabilized, cruciate retaining, all-polyethylene
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been suspended due to inability to obtain funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Jan 2020 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Jun 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.
This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). We will use radiostereometric analysis to assess the stability of the implants at 6 weeks, 3 months, 6 months, 1 year and 2 year post-operatively. The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient BMI significantly impacts the stability of AP tibial components.
Detailed description
With healthcare expenditures rising as our population ages, there have been significant efforts targeted towards streamlining costs associated with various medical treatments. One area of substantial spending in the orthopaedic surgery field is total joint replacements. The effort to reduce costs has sparked a renewed interest in the use of allpolyethylene (AP) tibial components in total knee arthroplasty (TKA).
In recent years, there has been ample research demonstrating that AP tibial components have performed as good as, or better, than metal-backed (MB) tibial components. Some studies have estimated that cost savings could be as high as 50% with routine use of AP tibial components. While sufficient literature exists demonstrating the equivalence or superiority of AP versus MB designs, there is a paucity of work done comparing different types of AP tibial components.
Tibial components in TKA can be of the posterior stabilizing (PS) or cruciate retaining (CR) variety. To date, we are unaware of any study that directly compares AP tibial PS components to AP tibial CR components.
Radiostereometric analysis (RSA) has evolved as an exceptionally precise and reliable method for assessing the migration of components in total joint arthroplasty. Using RSA data, it is possible to accurately predict, within the first 24 months post-operatively, the survival of a total joint arthroplasty. Furthermore, the use of RSA outcomes in arthroplasty research allows for adequately powered studies with significantly smaller sample sizes than previously required.
The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient body mass index (BMI) significantly impacts the stability of AP tibial components.
We will prospectively enroll patients who will be undergoing a total knee arthroplasty by one of the study investigators. Potentially eligible patients will have the project explained to them during their preadmission clinic visit prior to surgery and if interested a member of the research team will perform the informed consent process. Should a patient elect to participate in the study they will sign the informed consent form and complete demographics and baseline health related quality of life questionnaires including Oxford Knee, EQ-5D, and the VR-12, in addition to the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) which is already completed as per standard of care. The baseline demographic characteristics that will be collected include age, BMI, gender, and relevant medical comorbidities. Patients will be randomized to have either a PS or CR all-poly tibial component used during surgery. Randomization will be stratified by BMI to ensure equal distribution in both groups.
During surgery the surgeon will insert 6-9 tantalum beads in the proximal tibial, 6 beads in the polyeythylene tray, and another bead into the tip of the polyethylene stem. These beads will be used to measure migration of the implants on RSA imaging (radiostereometric analysis).
The RSA x-rays will be taken at baseline (2 weeks) and at the 6-week, 3 months, 6 months and 1 year and 2 year follow-up appointments. These images will be taken at Robarts Research Institute in the RSA analysis suite. At the 3month, 6 month, 1 year and 2 year visits we will also collect health related quality of life questionnaires including the WOMAC, Oxford Knee, EQ-5D and the VR-12.
Patients and data collector will be blinded to treatment arm. The person who will analyze the RSA images will be able to see which treatment arm participants belong to (based on viewing xrays) however the hypothesis of the study will not be revealed to them prior to analysis.
Intra-operative cost information will also be collected using institutional cost data in order to compare differences in OR costs between the two implant designs and across BMI categories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Stabilized | Experimental | Device: Posterior stabilized all-polyethylene tibial componentA posterior stabilized, all-polyethylene tibial component will be used during surgery. |
| Cruciate Retaining | Active comparator | Device: Cruciate retaining all-polyethylene tibial componentA cruciate retaining, all-polyethylene tibial component will be used during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteoarthritis
- primary total knee arthroplasty
- able to consent for themself
Key exclusion criteria (4 listed)
- inflammatory arthropathy
- fibromyalgia
- chronic pain syndrome
- previous distal femur or proximal tibia open reduction internal 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 |
|---|---|---|
| Posterior stabilized all-polyethylene tibial componentPatients randomized to this arm will have a Triathlon implant with a posterior stabilized, all-polyethylene tibial component used during surgery. | Device | Posterior Stabilized |
| Cruciate retaining all-polyethylene tibial componentPatients randomized to this arm will have a Triathlon implant with a cruciate retaining, all-polyethylene tibial component used during surgery. | Device | Cruciate Retaining |
Primary outcome
Implant Migration
Time frame: Change between baseline (taken at 2 weeks post-operatively) and 2 years
Comparison of the two component types using radiostereometric analysis imaging.
5 secondary outcomes
VR-12
Time frame: 2 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 years
Oxford Knee Score
Time frame: 2 years
EQ-5D
Time frame: 2 years
Cost
Time frame: Intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 20124081Gioe TJ, Maheshwari AV. The all-polyethylene tibial component in primary total knee arthroplasty. J Bone Joint Surg Am. 2010 Feb;92(2):478-87. doi: 10.2106/JBJS.I.00842.
- Background: PubMed 19968624Medel F, Kurtz SM, Klein G, Levine H, Sharkey P, Austin M, Kraay M, Rimnac CM. Clinical, surface damage and oxidative performance of poly II tibial inserts after long-term implantation. J Long Term Eff Med Implants. 2008;18(2):151-65. doi: 10.1615/jlongtermeffmedimplants.v18.i2.40.
- Background: PubMed 11021456Adalberth G, Nilsson KG, Bystrom S, Kolstad K, Milbrink J. Low-conforming all-polyethylene tibial component not inferior to metal-backed component in cemented total knee arthroplasty: prospective, randomized radiostereometric analysis study of the AGC total knee prosthesis. J Arthroplasty. 2000 Sep;15(6):783-92. doi: 10.1054/arth.2000.8101.
- Background: PubMed 26006786Yassin M, Garti A, Weissbrot M, Ashkenazi U, Khatib M, Robinson D. All-polyethylene tibial components are not inferior to metal-backed tibial components in long-term follow-up of knee arthroplasties. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1087-91. doi: 10.1007/s00590-015-1645-y. Epub 2015 May 26.
- Background: PubMed 15194094Norgren B, Dalen T, Nilsson KG. All-poly tibial component better than metal-backed: a randomized RSA study. Knee. 2004 Jun;11(3):189-96. doi: 10.1016/S0968-0160(03)00071-1.
- Background: PubMed 22972656Nouta KA, Verra WC, Pijls BG, Schoones JW, Nelissen RG. All-polyethylene tibial components are equal to metal-backed components: systematic review and meta-regression. Clin Orthop Relat Res. 2012 Dec;470(12):3549-59. doi: 10.1007/s11999-012-2582-2. Epub 2012 Sep 13.
- Background: PubMed 16195075Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
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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.
Edward Vasarhelyi, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior stabilized all-polyethylene tibial component and Cruciate retaining all-polyethylene tibial component in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 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: withdrawn, as of the sponsor's last update on 14 Sep 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Implant Migration (time frame: Change between baseline (taken at 2 weeks post-operatively) and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569670, which also lists 7 linked publications.
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 14 Sep 2021.