Evaluation of Fixation Achievable in Revision Total Knee Arthroplasty Implementing Latest-Generation Implant Technology
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Matthew Teeter, PhD
- Phone Number: 34957 519-685-8500
- Email: matthew.teeter@lhsc.on.ca
Study Contact Backup
- Name: Lyndsay Somerville, PhD
- Phone Number: 36645 519-685-8500
- Email: Lyndsay.Somerville@lhsc.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing a first total knee revision surgery
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Long-Stemmed with Hybrid Fixation
Participants will receive the Long-Stemmed revision implant with Hybrid Fixation during their surgery.
|
Long-stemmed revision implant with hybrid fixation for total knee arthroplasty
|
|
Experimental: Short-Stemmed with Augmented Fixation
Participants will receive the Short-Stemmed primary implant with Augmented Fixation during their surgery.
|
Short-stemmed primary implant with augmented fixation for total knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Migration Over Time
Time Frame: 0-2 weeks (baseline exam) to 1 year
|
Tibial component migration over time measured through radiostereometric analysis
|
0-2 weeks (baseline exam) to 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inducible displacement of the tibial component
Time Frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
|
Inducible displacement of implants to assess instantaneous fixation of implanted components measured through radiostereometric analysis
|
Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
|
|
Total costs
Time Frame: Surgery
|
Total costs of implants, bone cement and operating time will be recorded.
|
Surgery
|
|
KOOS Knee Survey
Time Frame: Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
|
Patient-reported measure to assess function, pain and stiffness.
|
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
|
Patient-reported measure to assess quality of life.
|
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
|
Clinician-reported outcome measure to assess function, pain and range of motion.
|
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
|
Patient-reported measure to assess quality of life
|
Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Brent A Lanting, MD, FRCSC, London Health Sciences Centre
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 109487
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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