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

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ClinicalTrials.gov Identifier: NCT00436982
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : December 8, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker European Operations BV

Brief 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.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Device: Cemented Triathlon total knee system Device: Duracon total knee system

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series
Study Start Date : February 2006
Primary Completion Date : November 2008
Study Completion Date : January 4, 2017

Arm Intervention/treatment
Active Comparator: Cemented Triathlon total knee system
The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Device: Cemented Triathlon total knee system
Orthopaedic implant
Active Comparator: Cemented Duracon total knee system
The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Device: Duracon total knee system
Orthopaedic implant



Primary Outcome Measures :
  1. Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 2 years ]
    To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.


Secondary Outcome Measures :
  1. Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 3 months, 1, 5, 7 and 10 years ]
    To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.

  2. Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score) [ Time Frame: [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, 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.

  3. Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]

    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/


  4. Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]

    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.


  5. Mean Operative Time [ Time Frame: intra-operative ]
    Skin to skin operative time

  6. Duration Hospital Stay [ Time Frame: preoperative to discharge ]
  7. Blood Loss [ Time Frame: intra-operative ]
    Blood loss during surgery



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients suffering exclusively from osteo arthritis (OA), Stage II-V [Ahlbäck, 1968] will be operated.
  2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
  3. 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.
  4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

  1. Previous major knee surgery
  2. Other significant disabling problems from the muscular-skeletal system than in the knees
  3. 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).
  4. Patients with active or suspected infection.
  5. Patients with malignancy - active malignancy.
  6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
  7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
  8. 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.
  9. Female patients planning a pregnancy during the course of the study.
  10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
  11. 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.
  12. Patients with other severe concurrent joint involvements, which can affect their outcome.
  13. 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.
  14. Patients under the protection of law (e.g. guardianship).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436982


Locations
Sweden
Hässleholm Hospital
Hässleholm, Sweden
Sponsors and Collaborators
Stryker European Operations BV
Investigators
Principal Investigator: Sören Toksvig-Larsen, ass. prof Department of ortopaedics, Hässleholm Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker European Operations BV
ClinicalTrials.gov Identifier: NCT00436982     History of Changes
Other Study ID Numbers: K-S-015 Triathlon RSA_1
K-S-015_1 ( Other Identifier: StrykerEuropean )
First Posted: February 19, 2007    Key Record Dates
Results First Posted: December 8, 2015
Last Update Posted: February 21, 2018
Last Verified: December 2017