Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 60
- Primary Endpoint
- Migration, measured by means of RSA
Study Overview
Brief Summary
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.
Detailed Description
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10 years results will be used to verify the predicted long-term survival results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. The subject is morbidly obese, defined as Body Mass Index (BMI) of >
- •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
- •Patient who is expected to 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
Exclusion Criteria
- Not provided
Arms & Interventions
All-polyethylene tibial components
Triathlon CS Knee System with all-polyethylene tibial components
Intervention: Triathlon CS Knee System with all-polyethylene tibial components (Device)
Metal-backed modular components
Triathlon CS Knee System with metal-backed modular components
Intervention: Triathlon CS Knee System with metal-backed modular components (Device)
Outcomes
Primary Outcomes
Migration, measured by means of RSA
Time Frame: 2 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Secondary Outcomes
- Migration, measured by means of RSA(10 years)
- Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of patient outcome with radiographic analysis(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)