AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Canada1 site
  • London Health Sciences Centre

    London, Ontario, N6A 5A5

Other trials in Canada

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.

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 groups in NCT03276351
Study groupRoleWhat they receive
Long-Stemmed with Hybrid FixationActive comparatorParticipants will receive the Long-Stemmed revision implant with Hybrid Fixation during their surgery.
Receives: Device: Long-Stemmed with Hybrid Fixation
Short-Stemmed with Augmented FixationExperimentalParticipants 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.

  1. 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)
  1. 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

  2. Total costs

    Total costs of implants, bone cement and operating time will be recorded.

    Measured: Surgery

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted8 Sep 2017
  2. Study start20 Apr 2018
  3. Primary completion12 Dec 2022
  4. Study completion12 Dec 2022

Resources

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)
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 24695919
  • Heesterbeek 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 27535438
  • Jensen 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 22795879
  • Kosse 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 27554783
  • Kurtz 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 24740658
  • Stambough 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in