- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358601
All-poly Versus Metal-backed
March 30, 2023 updated by: Region Skane
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
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.
Study Overview
Status
Active, not recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All-polyethylene tibial components
Triathlon PS Knee System with all-polyethylene tibial components
|
Primary Total Knee Replacement
Other Names:
|
Active Comparator: Metal-backed modular components
Triathlon PS Knee System with metal-backed modular components
|
Primary Total Knee Replacement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migration, measured by means of RSA
Time Frame: 10 years
|
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
|
10 years
|
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
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.
|
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
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
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).
|
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
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
|
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.
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
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
|
pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
Investigation of patient outcome with radiographic analysis
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
Plain radiographs will be obtained for assessment of fixation of the device.
|
pre-operative, 3 months, 1, 2, 5, 7 and 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2014
Primary Completion (Actual)
September 17, 2017
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Allpoly Triathlon PS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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