All-poly Versus Metal-backed

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Triathlon PS Knee System with all-polyethylene tibial components

Triathlon PS Knee System with metal-backed modular components

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

All-polyethylene tibial components

Metal-backed modular components

Arm Description

Triathlon PS Knee System with all-polyethylene tibial components

Triathlon PS Knee System with metal-backed modular components

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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.

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).

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.

Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.

The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100.questionnaire

Investigation of patient outcome with radiographic analysis

Plain radiographs will be obtained for assessment of fixation of the device.

Full Information

NCT ID

NCT04358601

First Posted

April 20, 2020

Last Updated

March 30, 2023

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT04358601

Brief Title

All-poly Versus Metal-backed

Official Title

Migration and Survival of All-polyethylene Tibial Components Compared to the Metal-backed Modular Components of the Triathlon PS Total Knee System. A RSA Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 1, 2014 (Actual)

Primary Completion Date

September 17, 2017 (Actual)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All-polyethylene tibial components

Arm Type

Experimental

Arm Description

Triathlon PS Knee System with all-polyethylene tibial components

Arm Title

Metal-backed modular components

Arm Type

Active Comparator

Arm Description

Triathlon PS Knee System with metal-backed modular components

Intervention Type

Device

Intervention Name(s)

Triathlon PS Knee System with all-polyethylene tibial components

Other Intervention Name(s)

Stryker Orthopaedics

Intervention Description

Primary Total Knee Replacement

Intervention Type

Device

Intervention Name(s)

Triathlon PS Knee System with metal-backed modular components

Other Intervention Name(s)

Stryker Orthopaedics

Intervention Description

Primary Total Knee Replacement

Primary Outcome Measure Information:

Title

Migration, measured by means of RSA

Description

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 Outcome Measure Information:

Title

Migration, measured by means of RSA

Description

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

Title

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

Description

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