Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design

NCT02924961 | Terminated

• 1 other identifier: P07.205
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Arthroplasty, Mechanical; Aseptic Loosening

Outcome Measures

Primary Outcomes (1)

• Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset)

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

  First or second day postoperatively, 6 months, 1 year

Secondary Outcomes (6)

• Migration, measured by means of RSA

  First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years

• Assessment of the knee flexion range by means of fluoroscopy during step-up motions

  6 months and 13 months postoperatively

• Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions

  6 months and 13 months postoperatively

• Assessment of the knee flexion range by means of fluoroscopy during lunge motions

  6 months and 13 months postoperatively

• Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions

  6 months and 13 months postoperatively

Study Arms (2)

Triathlon Mobile-bearing

EXPERIMENTAL

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

Device: Triathlon PS total knee system with mobile-bearing

Triathlon Fixed-bearing

ACTIVE COMPARATOR

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

Device: Triathlon PS total knee system with fixed-bearing

Interventions

Triathlon PS total knee system with mobile-bearing DEVICE

Also known as: Stryker Orthopaedics

Triathlon Mobile-bearing

Triathlon PS total knee system with fixed-bearing DEVICE

Also known as: Stryker Orthopaedics

Triathlon Fixed-bearing

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Stryker Nordic: collaborator

Study Sites (1)

Department of Orthopaedics, Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

Study Officials

• R.G.H.H. Nelissen, MD, PhD

  Head of Department of Orthopaedics, Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 5, 2016
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2016
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

NL (1)