- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02525601
Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented (TriathlonRSA)
March 30, 2023 updated by: Region Skane
Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining (CR) - Cemented vs. Uncemented
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR cemented vs. uncemented.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Skåne Län
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Hässleholm, Skåne Län, Sweden, 281 38
- Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
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-
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients suffering exclusively from osteo arthritis, Stage II-V [Ahlbäck Trauma Score, 1968 391] will be operated.
- Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
- Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Exclusion Criteria:
- Previous major knee surgery
- Other significant disabling problems from the muscular-skeletal system than in the knees
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
- Patients with active or suspected infection.
- Patients with malignancy - active malignancy.
- Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
- Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- Female patients planning a pregnancy during the course of the study.
- Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Patients with other severe concurrent joint involvements, which can affect their outcome.
- Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
- Patients under the protection of law (e.g. guardianship).
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
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Triathlon CR cemented
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation.
The aim with this study is to evaluate the uncemented Peri-Apatite (PA) knee fixation and migration properties versus the cemented version.
|
Implantation of Knee Prosthesis
|
Active Comparator: Triathlon CR uncemented
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation.
The aim with this study is to evaluate the uncemented PA knee fixation and migration properties versus the cemented version.
|
Implantation of Knee Prosthesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Time Frame: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes
|
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric as a predictor of late mechanical loosening.
|
10 years follow-up; UPDATE: time frame extended up to 15 years outcomes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigation of patient outcome with radiographic analysis
Time Frame: 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
|
Plain radiographs will be obtained for assessment of fixation of the device.
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3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
|
Investigation of clinical performance and patient outcome with Knee Society Score (KSS)
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 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; UPDATE: extended 12 and 15 years
|
Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 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).
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pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 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; UPDATE: extended 12 and 15 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; UPDATE: extended 12 and 15 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)
March 1, 2009
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
May 1, 2025
Study Registration Dates
First Submitted
June 11, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 17, 2015
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
Other Study ID Numbers
- K-S-015 Triathlon RSA _5
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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