Evaluation of Fixation Achievable in Revision Total Knee Arthroplasty Implementing Latest-Generation Implant Technology

NCT03276351 | Completed

• 1 other identifier: 109487
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 (radiostereometric analysis) to assess implant movement over time. The investigators are also comparing costs and patient-reported outcomes between the groups.

Conditions

Knee Osteoarthritis; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Implant Migration Over Time

  Tibial component migration over time measured through radiostereometric analysis

  0-2 weeks (baseline exam) to 1 year

Secondary Outcomes (6)

• Inducible displacement of the tibial component

  Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years

• Total costs

  Surgery

• KOOS Knee Survey

  Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years

• The Veterans Rand 12 Item Health Survey (VR-12)

  Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years

• Knee Society score

  Pre-operatively, 6 weeks, 3 months, 6 months, 1 year, and 2 years

Study Arms (2)

Long-Stemmed with Hybrid Fixation

ACTIVE COMPARATOR

Participants will receive the Long-Stemmed revision implant with Hybrid Fixation during their surgery.

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.

Device: Short-Stemmed with Augmented Fixation

Interventions

Long-Stemmed with Hybrid Fixation DEVICE

Long-stemmed revision implant with hybrid fixation for total knee arthroplasty

Long-Stemmed with Hybrid Fixation

Short-Stemmed with Augmented Fixation DEVICE

Short-stemmed primary implant with augmented fixation for total knee arthroplasty

Short-Stemmed with Augmented Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a first total knee revision surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (6)

• 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.

  PMID: 24695919 BACKGROUND

• 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.

  PMID: 27535438 BACKGROUND

• 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.

  PMID: 22795879 BACKGROUND

• 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.

  PMID: 27554783 BACKGROUND

• 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.

  PMID: 24740658 BACKGROUND

• 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.

  PMID: 25452369 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brent A Lanting, MD, FRCSC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded so that they do not know what type of implant construct they received. It will not be possible to blind the surgeon or the individual performing the RSA image processing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: April 20, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CA (1)