Arthroplasty, Replacement, KneeTriathlonRSANCT03198533
Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit
A study testing Triathlon PA and Triathlon Pressfit in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Triathlon PA and Triathlon Pressfit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jul 2007to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering exclusively from OA, Stage II-V [Ahlbäck, 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Skåne County, 281 38
About this study
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.
Read the 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 PA vs. Triathlon Pressfit
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Triathlon PA, Triathlon Pressfit
- Keywords
- Knee, Arthrosis, Implant
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon PADevice
Implantation of Knee Prosthesis
Triathlon PressfitDevice
Implantation of Knee Prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Triathlon PA | Active comparator | Triathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit. Receives: Device: Triathlon PA |
| Triathlon Pressfit | Active comparator | Triathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit. Receives: Device: Triathlon Pressfit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roentgen Stereophotogrammetric Analysis (RSA)
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Assessment of fixation and stability of the Triathlon total knee prosthesis by RSA as a predictor of late mechanical loosening.
Measured: 10 years follow-up
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Measured: 3 months, 1, 2, 5, 7 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start10 Jul 2007
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sören Toksvig-Larsen, MD, Principal investigator, Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198533
- Sponsor's protocol ID
- K-S-015 Triathlon RSA _3
- Acronym
- TriathlonRSA
- Status last verified
- Feb 2024
- First submitted
- 9 May 2017
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit
- ClinicalTrials.gov ID
- NCT03198533
- Acronym / sponsor ID
- TriathlonRSA / K-S-015 Triathlon RSA _3
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Knee, Arthrosis, Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2007 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 PA vs. Triathlon Pressfit
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triathlon PA | Active comparator | Device: Triathlon PATriathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit. |
| Triathlon Pressfit | Active comparator | Device: Triathlon PressfitTriathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering exclusively from OA, Stage II-V [Ahlbäck, 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triathlon PAImplantation of Knee Prosthesis | Device | Triathlon PA |
| Triathlon PressfitImplantation of Knee Prosthesis | Device | Triathlon Pressfit |
Primary outcome
Roentgen Stereophotogrammetric Analysis (RSA)
Time frame: 10 years follow-up
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Assessment of fixation and stability of the Triathlon total knee prosthesis by RSA as a predictor of late mechanical loosening.
4 secondary outcomes
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
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
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
Investigation of patient outcome with radiographic analysis
Time frame: 3 months, 1, 2, 5, 7 and 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sören Toksvig-Larsen, MD principal investigator
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon PA and Triathlon Pressfit in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roentgen Stereophotogrammetric Analysis (RSA) (time frame: 10 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.