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NCT Number: NCT02525588

Polyethylene Wear Study on the Triathlon Total Knee Prosthesis

Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.

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Key information

Conditions

Arthroplasty, Replacement, Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer

Zoetermeer, South Holland, 2725 NA, Netherlands

About this study

The goal of this study is to compare conventional UHMWPE with X3 highly cross-linked polyethylene in a CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA) by means of RSA and clinical evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
  • Patients with a pre-operative knee score of < 70.
  • Patients scheduled to undergo primary total knee replacement with any of the following indication.
  • Painful and disabled knee joint resulting from osteoarthritis.
  • One or more compartments are involved.
  • Need to obtain pain relief and improve function.
  • Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
  • A good nutritional state of the patient.
  • Full skeletal maturity of the patient, patients who are at least 18 years of age.
  • Patients of either sex.

Exclusion criteria

  • The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
  • Skeletal immaturity of the patient, patients who are less than 18 years of age.
  • Patient has a flexion contracture of 15° and more.
  • Patient has a varus/valgus contracture of 15° and more.
  • Patients with a pre-operative knee score of >70.
  • The subject has a history of total or unicompartmental reconstruction of the affected joint.
  • The subject will be operated bilaterally.
  • Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).
  • Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).
  • The subject has an active or suspected latent infection in or about the knee joint.
  • Osteomyelitis.
  • Sepsis.
  • Patients who will need lower limb joint replacement for another joint within one year.
  • The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
  • The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
  • The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has had a knee fusion to the affected joint.
  • Female patients planning a pregnancy during the course of the study.
  • The patient is unable or unwilling to sign the Informed Consent specific to this study.

Treatment and study plan

Triathlon CS fixed bearing total knee prosthesis

Device

The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.

Primary outcomes

  1. Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).

    Time frame: 1, 2 and 5 years follow-up

    RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.

Secondary outcomes

  1. Assessment of Prosthetic Migration Results After Two Years by RSA.

    Time frame: 3 and 6 months,1, 2 and 5 years follow-up

    RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components.

  2. Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

    Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 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.

  3. Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)

    Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

    The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

  4. Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire

    Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

    The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.

    With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

  5. Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire

    Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

    The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre Roentgen Stereophotogrammetric Analysis (RSA) Study

Acronym: X3vsN2Vac

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2015
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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