Knee OsteoarthritisNCT03276351
Evaluation of Fixation Achievable in Revision Total Knee Arthroplasty Implementing Latest-Generation Implant Technology
A study testing Long-Stemmed with Hybrid Fixation and Short-Stemmed with Augmented Fixation in people with Knee Osteoarthritis and Knee Arthroplasty, 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 prospective randomized control trial that aims to investigate fixation of implants after revision total knee replacement. The investigators are comparing long-stemmed revision implants with hybrid cementation to short-stemmed primary implants with augment using a special type of x-ray imaging… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthroplasty
- What is being tested?
- Long-Stemmed with Hybrid Fixation and Short-Stemmed with Augmented Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2018to 12 Dec 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
- Patients undergoing a first total knee revision surgery
Who cannot join
- Patients who have previously undergone revision knee surgery
- Patients that require a hinged revision implant
- Patients that do not speak or understand English (questionnaires provided in English)
- Patients with any active or suspected latent infection in or about the knee joint
- Patients with bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis
- Patients that live >100km from our centre (as such individuals are less likely to be available for the required follow-up appointments)
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized control trial that aims to investigate fixation of implants after revision total knee replacement. The investigators are comparing long-stemmed revision implants with hybrid cementation to short-stemmed primary implants with augment using a special type of x-ray imaging (radiostereometric analysis) to assess implant movement over time. The investigators are also comparing costs and patient-reported outcomes between the groups.
Read the detailed description
The demand for total knee replacement (TKR) continues to grow, especially for younger patients who are at a greater risk of outliving the useful lifetime of their implants, thus requiring revision surgery (Aggarwal et al., 2014; Stambough et al., 2014). Rates of revision TKR are growing at an even faster rate than primary TKR. Between 2009-10, the incidence of primary TKR grew by 9.4% in the U.S., while revision TKR grew by 17.1% (Kurtz et al., 2014). Revision occurs for failures such as loosening, infection, or wear. Unfortunately, patients undergoing revision TKR are roughly 6 times more likely to require re-revision compared to patients undergoing primary TKR, further increasing the revision burden. Standard of care for revision TKR has evolved, in search of long-lasting fixation and improved patient outcomes. In many centres, the current standard of care is to use revision TKR implants with long stems for enhanced fixation. Surgeon preference is variable, however, as to whether these stems will be fully cemented, or whether only the most proximal aspect of the baseplate will be cemented (hybrid fixation). While most common, these long-stemmed revision implants have suffered from poor survivorship, are technically demanding to implant, and can result in poor patient outcomes, including ongoing pain. Over the past decade porous metal augments have gained favour. These devices interface between the defective bone and the implant, aiding fixation. The first augment of its kind are the Trabecular Metal cone augments from Zimmer. Although an improvement in principle, they have a number of drawbacks including poor fit with most implant systems, increasing technical challenge and requiring intra-operative customization, which lengthens the surgery. More recently, Stryker Tritanium augments have been introduced that offer a closer fit with Triathlon revision implants, decreasing operative time. This closeness of fit also provides an opportunity to rethink the utilization of long stems when porous augments are used. Ultimately, the goal would be for porous metal augments to completely fill all bone defects, essentially enabling a more primary-like TKR to be performed, enhancing patient outcomes. The gold standard for measurement of implant fixation over time is radiostereometric analysis (RSA). At the time of surgery, 0.8-1.0 mm Tantalum beads (typically n = 6-8 per region of interest) are inserted into the bone surrounding the implant of interest, and occasionally also into the polyethylene liner or insert of the implant. RSA exams are then acquired within the first 2 weeks post-operation, and again at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Each exam involves a stereo x-ray acquisition with a calibration unit to reconstruct the 3D location of the implant relative to the marker beads. Across each exam, the migration of the implant relative to the marker beads is tracked compared to the baseline exam acquired within the first 2 weeks. RSA is extremely precise and accurate, and is able to track migrations on the order of 10's of microns. Large early migrations within the first 1-2 years post-operation are predictive of eventual implant loosening and failure. RSA can also be used to measure inducible displacement of implants to assess instantaneous fixation of implanted components. These RSA exams compare a supine, unloaded image of the patient's joint to a standing, loaded image of their joint, to determine whether any movement occurs between the implant and marker beads with loading. To our knowledge, only three published RSA studies of revision TKR exist in the literature. Jensen et al. (2012) published a 2-year study with 40 patients comparing cement reconstruction to Trabecular Metal cones. They found no significant difference between groups for migration at 2 years, and determined that use of the Trabecular Metal cones resulted in better early stability with reduced irregular motion patterns compared to using hybrid cement reconstruction. Heesterbeek et al. (2016) published a 2-year study with 32 patients that compared hybrid to fully cemented stem fixation using the Legion revision system, which was followed up to 6.5 years by Kosse et al. (2017). At both follow-up time points, there was no difference in overall migration between the hybrid and fully cemented stem groups. Taken together, these studies do not reflect the latest thinking in revision knee surgery, do not account for the current generation of augment design, do not directly compare augments with hybrid and fully cemented fixation, and do not correlate fixation and patient outcome scores.
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Being tested
- Long-Stemmed with Hybrid Fixation, Short-Stemmed with Augmented Fixation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Stemmed with Hybrid FixationDevice
Long-stemmed revision implant with hybrid fixation for total knee arthroplasty
Short-Stemmed with Augmented FixationDevice
Short-stemmed primary implant with augmented fixation for total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Long-Stemmed with Hybrid Fixation | Active comparator | Participants will receive the Long-Stemmed revision implant with Hybrid Fixation during their surgery. Receives: Device: Long-Stemmed with Hybrid Fixation |
| Short-Stemmed with Augmented Fixation | Experimental | Participants will receive the Short-Stemmed primary implant with Augmented Fixation during their surgery. Receives: Device: Short-Stemmed with Augmented Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Migration Over Time
Tibial component migration over time measured through radiostereometric analysis
Measured: 0-2 weeks (baseline exam) to 1 year
Secondary outcomes (6)
Inducible displacement of the tibial component
Inducible displacement of implants to assess instantaneous fixation of implanted components measured through radiostereometric analysis
Measured: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Total costs
Total costs of implants, bone cement and operating time will be recorded.
Measured: Surgery
KOOS Knee Survey
Patient-reported measure to assess function, pain and stiffness.
Measured: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
The Veterans Rand 12 Item Health Survey (VR-12)
Patient-reported measure to assess quality of life.
Measured: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Knee Society score
Clinician-reported outcome measure to assess function, pain and range of motion.
Measured: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Euro-Quol Group EQ-5D
Patient-reported measure to assess quality of life
Measured: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start20 Apr 2018
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomized to one of the two groups by block randomization using concealed envelopes, with the randomization and group assignment performed by a study coordinator at the time of surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brent A Lanting, MD, FRCSC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276351
- Sponsor's protocol ID
- 109487
- Status last verified
- Apr 2023
- First submitted
- 6 Sep 2017
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aggarwal VK, Goyal N, Deirmengian G, Rangavajulla A, Parvizi J, Austin MS. Revision total knee arthroplasty in the young patient: is there trouble on the horizon? J Bone Joint Surg Am. 2014 Apr 2;96(7):536-42. doi: 10.2106/JBJS.M.00131.
PubMed 24695919Heesterbeek PJ, Wymenga AB, van Hellemondt GG. No Difference in Implant Micromotion Between Hybrid Fixation and Fully Cemented Revision Total Knee Arthroplasty: A Randomized Controlled Trial with Radiostereometric Analysis of Patients with Mild-to-Moderate Bone Loss. J Bone Joint Surg Am. 2016 Aug 17;98(16):1359-69. doi: 10.2106/JBJS.15.00909.
PubMed 27535438Jensen CL, Petersen MM, Schroder HM, Flivik G, Lund B. Revision total knee arthroplasty with the use of trabecular metal cones: a randomized radiostereometric analysis with 2 years of follow-up. J Arthroplasty. 2012 Dec;27(10):1820-1826.e2. doi: 10.1016/j.arth.2012.04.036. Epub 2012 Jul 13.
PubMed 22795879Kosse NM, van Hellemondt GG, Wymenga AB, Heesterbeek PJ. Comparable Stability of Cemented vs Press-Fit Placed Stems in Revision Total Knee Arthroplasty With Mild to Moderate Bone Loss: 6.5-Year Results From a Randomized Controlled Trial With Radiostereometric Analysis. J Arthroplasty. 2017 Jan;32(1):197-201. doi: 10.1016/j.arth.2016.06.003. Epub 2016 Jul 14.
PubMed 27554783Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am. 2014 Apr 16;96(8):624-30. doi: 10.2106/JBJS.M.00285.
PubMed 24740658Stambough JB, Clohisy JC, Barrack RL, Nunley RM, Keeney JA. Increased risk of failure following revision total knee replacement in patients aged 55 years and younger. Bone Joint J. 2014 Dec;96-B(12):1657-62. doi: 10.1302/0301-620X.96B12.34486.
PubMed 25452369
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fixation Achievable in Revision Total Knee Arthroplasty Implementing Latest-Generation Implant Technology
- ClinicalTrials.gov ID
- NCT03276351
- Acronym / sponsor ID
- 109487
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 8 Sep 2017 (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 prospective randomized control trial that aims to investigate fixation of implants after revision total knee replacement. The investigators are comparing long-stemmed revision implants with hybrid cementation to short-stemmed primary implants with augment using a special type of x-ray imaging (radiostereometric analysis) to assess implant movement over time. The investigators are also comparing costs and patient-reported outcomes between the groups.
Detailed description
The demand for total knee replacement (TKR) continues to grow, especially for younger patients who are at a greater risk of outliving the useful lifetime of their implants, thus requiring revision surgery (Aggarwal et al., 2014; Stambough et al., 2014). Rates of revision TKR are growing at an even faster rate than primary TKR. Between 2009-10, the incidence of primary TKR grew by 9.4% in the U.S., while revision TKR grew by 17.1% (Kurtz et al., 2014). Revision occurs for failures such as loosening, infection, or wear. Unfortunately, patients undergoing revision TKR are roughly 6 times more likely to require re-revision compared to patients undergoing primary TKR, further increasing the revision burden. Standard of care for revision TKR has evolved, in search of long-lasting fixation and improved patient outcomes. In many centres, the current standard of care is to use revision TKR implants with long stems for enhanced fixation. Surgeon preference is variable, however, as to whether these stems will be fully cemented, or whether only the most proximal aspect of the baseplate will be cemented (hybrid fixation). While most common, these long-stemmed revision implants have suffered from poor survivorship, are technically demanding to implant, and can result in poor patient outcomes, including ongoing pain. Over the past decade porous metal augments have gained favour. These devices interface between the defective bone and the implant, aiding fixation. The first augment of its kind are the Trabecular Metal cone augments from Zimmer. Although an improvement in principle, they have a number of drawbacks including poor fit with most implant systems, increasing technical challenge and requiring intra-operative customization, which lengthens the surgery. More recently, Stryker Tritanium augments have been introduced that offer a closer fit with Triathlon revision implants, decreasing operative time. This closeness of fit also provides an opportunity to rethink the utilization of long stems when porous augments are used. Ultimately, the goal would be for porous metal augments to completely fill all bone defects, essentially enabling a more primary-like TKR to be performed, enhancing patient outcomes. The gold standard for measurement of implant fixation over time is radiostereometric analysis (RSA). At the time of surgery, 0.8-1.0 mm Tantalum beads (typically n = 6-8 per region of interest) are inserted into the bone surrounding the implant of interest, and occasionally also into the polyethylene liner or insert of the implant. RSA exams are then acquired within the first 2 weeks post-operation, and again at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Each exam involves a stereo x-ray acquisition with a calibration unit to reconstruct the 3D location of the implant relative to the marker beads. Across each exam, the migration of the implant relative to the marker beads is tracked compared to the baseline exam acquired within the first 2 weeks. RSA is extremely precise and accurate, and is able to track migrations on the order of 10's of microns. Large early migrations within the first 1-2 years post-operation are predictive of eventual implant loosening and failure. RSA can also be used to measure inducible displacement of implants to assess instantaneous fixation of implanted components. These RSA exams compare a supine, unloaded image of the patient's joint to a standing, loaded image of their joint, to determine whether any movement occurs between the implant and marker beads with loading. To our knowledge, only three published RSA studies of revision TKR exist in the literature. Jensen et al. (2012) published a 2-year study with 40 patients comparing cement reconstruction to Trabecular Metal cones. They found no significant difference between groups for migration at 2 years, and determined that use of the Trabecular Metal cones resulted in better early stability with reduced irregular motion patterns compared to using hybrid cement reconstruction. Heesterbeek et al. (2016) published a 2-year study with 32 patients that compared hybrid to fully cemented stem fixation using the Legion revision system, which was followed up to 6.5 years by Kosse et al. (2017). At both follow-up time points, there was no difference in overall migration between the hybrid and fully cemented stem groups. Taken together, these studies do not reflect the latest thinking in revision knee surgery, do not account for the current generation of augment design, do not directly compare augments with hybrid and fully cemented fixation, and do not correlate fixation and patient outcome scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of the two groups by block randomization using concealed envelopes, with the randomization and group assignment performed by a study coordinator at the time of surgery.
| Arm | Type | Receives |
|---|---|---|
| Long-Stemmed with Hybrid Fixation | Active comparator | Device: Long-Stemmed with Hybrid FixationParticipants will receive the Long-Stemmed revision implant with Hybrid Fixation during their surgery. |
| Short-Stemmed with Augmented Fixation | Experimental | Device: Short-Stemmed with Augmented FixationParticipants will receive the Short-Stemmed primary implant with Augmented Fixation during their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a first total knee revision surgery
Key exclusion criteria (6 listed)
- Patients who have previously undergone revision knee surgery
- Patients that require a hinged revision implant
- Patients that do not speak or understand English (questionnaires provided in English)
- Patients with any active or suspected latent infection in or about the knee joint
- Patients with bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis
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 |
|---|---|---|
| Long-Stemmed with Hybrid FixationLong-stemmed revision implant with hybrid fixation for total knee arthroplasty | Device | Long-Stemmed with Hybrid Fixation |
| Short-Stemmed with Augmented FixationShort-stemmed primary implant with augmented fixation for total knee arthroplasty | Device | Short-Stemmed with Augmented Fixation |
Primary outcome
Implant Migration Over Time
Time frame: 0-2 weeks (baseline exam) to 1 year
Tibial component migration over time measured through radiostereometric analysis
6 secondary outcomes
Inducible displacement of the tibial component
Time frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Total costs
Time frame: Surgery
KOOS Knee Survey
Time frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
The Veterans Rand 12 Item Health Survey (VR-12)
Time frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Knee Society score
Time frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Euro-Quol Group EQ-5D
Time frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 24695919Aggarwal VK, Goyal N, Deirmengian G, Rangavajulla A, Parvizi J, Austin MS. Revision total knee arthroplasty in the young patient: is there trouble on the horizon? J Bone Joint Surg Am. 2014 Apr 2;96(7):536-42. doi: 10.2106/JBJS.M.00131.
- Background: PubMed 27535438Heesterbeek PJ, Wymenga AB, van Hellemondt GG. No Difference in Implant Micromotion Between Hybrid Fixation and Fully Cemented Revision Total Knee Arthroplasty: A Randomized Controlled Trial with Radiostereometric Analysis of Patients with Mild-to-Moderate Bone Loss. J Bone Joint Surg Am. 2016 Aug 17;98(16):1359-69. doi: 10.2106/JBJS.15.00909.
- Background: PubMed 22795879Jensen CL, Petersen MM, Schroder HM, Flivik G, Lund B. Revision total knee arthroplasty with the use of trabecular metal cones: a randomized radiostereometric analysis with 2 years of follow-up. J Arthroplasty. 2012 Dec;27(10):1820-1826.e2. doi: 10.1016/j.arth.2012.04.036. Epub 2012 Jul 13.
- Background: PubMed 27554783Kosse NM, van Hellemondt GG, Wymenga AB, Heesterbeek PJ. Comparable Stability of Cemented vs Press-Fit Placed Stems in Revision Total Knee Arthroplasty With Mild to Moderate Bone Loss: 6.5-Year Results From a Randomized Controlled Trial With Radiostereometric Analysis. J Arthroplasty. 2017 Jan;32(1):197-201. doi: 10.1016/j.arth.2016.06.003. Epub 2016 Jul 14.
- Background: PubMed 24740658Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am. 2014 Apr 16;96(8):624-30. doi: 10.2106/JBJS.M.00285.
- Background: PubMed 25452369Stambough JB, Clohisy JC, Barrack RL, Nunley RM, Keeney JA. Increased risk of failure following revision total knee replacement in patients aged 55 years and younger. Bone Joint J. 2014 Dec;96-B(12):1657-62. doi: 10.1302/0301-620X.96B12.34486.
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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.
Brent A Lanting, MD, FRCSC 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 Long-Stemmed with Hybrid Fixation and Short-Stemmed with Augmented Fixation in people with Knee Osteoarthritis and Knee Arthroplasty, 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 1 inclusion and 6 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 5 Apr 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Over Time (time frame: 0-2 weeks (baseline exam) to 1 year). 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 NCT03276351, which also lists 6 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 5 Apr 2023.