Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design

Sponsor
Leiden University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02924961
Collaborator
Stryker Nordic (Industry)
48
1
2
94
0.5

Study Details

Study Description

Brief Summary

The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.

Condition or Disease Intervention/Treatment Phase
  • Device: Triathlon PS total knee system with mobile-bearing
  • Device: Triathlon PS total knee system with fixed-bearing
N/A

Detailed Description

The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.

Objectives:
  1. To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.

  2. To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)

  3. To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.

  4. Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Triathlon Mobile-bearing

Primary total knee replacement with cemented Triathlon posterior stabilized mobile-bearing

Device: Triathlon PS total knee system with mobile-bearing
Other Names:
  • Stryker Orthopaedics
  • Active Comparator: Triathlon Fixed-bearing

    Primary total knee replacement with cemented Triathlon posterior stabilized fixed-bearing

    Device: Triathlon PS total knee system with fixed-bearing
    Other Names:
  • Stryker Orthopaedics
  • Outcome Measures

    Primary Outcome Measures

    1. Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset) [First or second day postoperatively, 6 months, 1 year]

      Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)

    Secondary Outcome Measures

    1. Migration, measured by means of RSA [First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years]

      Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)

    2. Assessment of the knee flexion range by means of fluoroscopy during step-up motions [6 months and 13 months postoperatively]

      Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees).

    3. Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions [6 months and 13 months postoperatively]

      Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees).

    4. Assessment of the knee flexion range by means of fluoroscopy during lunge motions [6 months and 13 months postoperatively]

      Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees).

    5. Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions [6 months and 13 months postoperatively]

      Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees).

    6. Investigation of clinical performance and patient outcome with the Knee Society Score (KSS) [Within 3 months prior to surgery, 6 months postoperatively, 1 year and and annually thereafter up to 20 years]

      The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty.

    • Patient is capable of giving informed consent and expressing a willingness to comply with this study

    • Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees)

    • The ability to perform a lunge and step-up motion without the help of bars or a cane.

    • No or slight pain during activity according to the Knee Society Pain Score

    Exclusion Criteria:
    • The patient is unable or unwilling to sign the Informed Consent specific to this study

    • The individual has a functional impairment of any other lower extremity joint besides the operated knee

    • Patient has a flexion contracture of 15° and more

    • Patient has a varus/valgus contracture of 15° and more

    • Patients requiring revision arthroplasty

    • The patient does not understand the Dutch or English language good enough to participate.

    • The use of walking aids

    • The inability to walk more than 500 meters

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Orthopaedics, Leiden University Medical Center Leiden Netherlands 2300RC

    Sponsors and Collaborators

    • Leiden University Medical Center
    • Stryker Nordic

    Investigators

    • Principal Investigator: R.G.H.H. Nelissen, MD, PhD, Head of Department of Orthopaedics, Leiden University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    R.G.H.H. Nelissen, Prof. dr., Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02924961
    Other Study ID Numbers:
    • P07.205
    First Posted:
    Oct 5, 2016
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Mar 7, 2018