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Clinical Trials/NCT02525588
NCT02525588CompletedNot Applicable

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

Stryker Orthopaedics1 site in 1 country100 target enrollmentStarted: September 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 <
  • •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 >
  • •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 >
  • •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.
  • •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.

Arms & Interventions

Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac)

Active Comparator

Conventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis

Intervention: Triathlon CS fixed bearing total knee prosthesis (Device)

Highly cross-linked polyethylene (X3)

Active Comparator

X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis

Intervention: Triathlon CS fixed bearing total knee prosthesis (Device)

Outcomes

Primary Outcomes

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

  • Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
  • Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
  • Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
  • Assessment of Prosthetic Migration Results After Two Years by RSA.(3 and 6 months,1, 2 and 5 years follow-up)
  • Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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