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Arthroplasty, Replacement, KneeNCT00436982

Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

A study testing Cemented Triathlon total knee system and Duracon total knee system in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Cemented Triathlon total knee system and Duracon total knee system
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
Feb 2006to 4 Jan 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 osteo arthritis (OA), Stage II-V [Ahlbäck, 1968] 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.
Show all 14Show fewer
  • 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

  • Hässleholm Hospital

    Hässleholm

Other trials in Sweden

About this study

Official title: Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series

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 evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.

Being tested
Cemented Triathlon total knee system, Duracon total knee system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cemented Triathlon total knee systemDevice

    Orthopaedic implant

  • Duracon total knee systemDevice

    Orthopaedic implant

Study groups in NCT00436982
Study groupRoleWhat they receive
Cemented Triathlon total knee systemActive comparatorThe Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Receives: Device: Cemented Triathlon total knee system
Cemented Duracon total knee systemActive comparatorThe Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Receives: Device: Duracon total knee system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Roentgen Stereophotogrammetric Analysis (RSA)

    To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.

    Measured: 2 years

Secondary outcomes (7)

  1. Roentgen Stereophotogrammetric Analysis (RSA)

    To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.

    Measured: 3 months, 1, 5, 7 and 10 years

  2. Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)

    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, 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: [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]

  3. Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire

    KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) 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) is calculated for each subscale.

    [taken from User Guide] http://www.koos.nu/

    Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  4. Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire

    The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.

    NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected.

    Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  5. Mean Operative Time

    Skin to skin operative time

    Measured: intra-operative

  6. Duration Hospital Stay

    Measured: preoperative to discharge

  7. Blood Loss

    Blood loss during surgery

    Measured: intra-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2007 (estimated)
  2. Study startFeb 2006
  3. Primary completionNov 2008
  4. Study completion4 Jan 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00436982
Sponsor's protocol ID
K-S-015 Triathlon RSA_1
Other IDs
K-S-015_1
Status last verified
Feb 2024
First submitted
16 Feb 2007
Last updated
22 Feb 2024
Data monitoring committee
No

Publications

  • Molt M, Ljung P, Toksvig-Larsen S. Does a new knee design perform as well as the design it replaces? Bone Joint Res. 2012 Dec 1;1(12):315-23. doi: 10.1302/2046-3758.112.2000064. Print 2012 Dec.

    PubMed 23610663

  • Molt M, Toksvig-Larsen S. Similar early migration when comparing CR and PS in Triathlon TKA: A prospective randomised RSA trial. Knee. 2014 Oct;21(5):949-54. doi: 10.1016/j.knee.2014.05.012. Epub 2014 Jun 7.

    PubMed 24974301

Questions about this trial

What is this clinical trial studying?

A study testing Cemented Triathlon total knee system and Duracon total knee system 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 22 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?

Yes. Results are posted in the registry (first posted 8 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00436982, which also lists 2 linked publications.

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 22 Feb 2024.

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