All-poly Versus Metal-backed

N/AActive Not RecruitingNCT04358601

Region Skane60 enrolled

Overview

The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Osteoarthritis

Interventions

Triathlon PS Knee System with all-polyethylene tibial componentsDEVICE

Primary Total Knee Replacement

Triathlon PS Knee System with metal-backed modular componentsDEVICE

Primary Total Knee Replacement

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

1\. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40. 2. Patient has a flexion contracture of 15° and more. 3. Patient has a varus/valgus contracture of 15° and more. 4. Patients with a pre-operative knee score of \>70. 5. The subject has a history of total or unicompartmental reconstruction of the affected joint. 6. The subject will be operated bilaterally. 7. 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). 8. 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). 9. The subject has an active or suspected latent infection in or about the knee joint. 10. Osteomyelitis 11. Sepsis 12. Patient who is expected to need lower limb joint replacement for another joint within one year. 13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female patients planning a pregnancy during the course of the study. 19. The patient is unable or unwilling to sign the Informed Consent specific to this study

Outcomes

Primary Outcomes

Migration, measured by means of RSA

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

Time frame: 2 years

Secondary Outcomes

Migration, measured by means of RSA

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

Time frame: 10 years

Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)

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.

Time frame: 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

KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

Time frame: 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

The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

Data from ClinicalTrials.gov

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