Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatment triathlon cs fixed bearing total knee prosthesis
Sponsor Stryker European Operations BV
Start date September 2011
End date June 2019
Trial size 100 participants
Trial identifier NCT02525588, K-S-039

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis
triathlon cs fixed bearing total knee prosthesis
The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
(Active Comparator)
X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis
triathlon cs fixed bearing total knee prosthesis
The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.

Primary Outcomes

Measure
Assessment of polyethylene inlay wear by Roentgen Stereophotogrammetric Analysis (RSA).
time frame: 5 years follow-up

Secondary Outcomes

Measure
Assessment of prosthetic migration results after two years by RSA.
time frame: 2 years follow-up
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
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Patients with a pre-operative knee score of < 70. 3. 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. 4. Need to obtain pain relief and improve function. 5. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations. 6. A good nutritional state of the patient. 7. Full skeletal maturity of the patient, patients who are at least 18 years of age. 8. Patients of either sex. Exclusion Criteria: 1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 2. Skeletal immaturity of the patient, patients who are less than 18 years of age. 3. Patient has a flexion contracture of 15° and more. 4. Patient has a varus/valgus contracture of 15° and more. 5. Patients with a pre-operative knee score of >70. 6. The subject has a history of total or unicompartmental reconstruction of the affected joint. 7. The subject will be operated bilaterally. 8. 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). 9. 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). 10. The subject has an active or suspected latent infection in or about the knee joint. 11. Osteomyelitis. 12. Sepsis. 13. Patients who will need lower limb joint replacement for another joint within one year. 14. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 15. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 16. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 17. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 18. The subject has had a knee fusion to the affected joint. 19. Female patients planning a pregnancy during the course of the study. 20. The patient is unable or unwilling to sign the Informed Consent specific to this study.

Additional Information

Official title Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre RSA Study
Principal investigator H. Kaptijn, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.