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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker European Operations BV
ClinicalTrials.gov Identifier:
NCT00436982
First received: February 16, 2007
Last updated: April 6, 2016
Last verified: April 2016
  Purpose
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 Intervention
Arthroplasty, Replacement, Knee
Device: Cemented Triathlon total knee system
Device: Duracon total knee system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series

Further study details as provided by Stryker European Operations BV:

Primary Outcome Measures:
  • Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To compare the maximum total point motion of the Triathlon and Duracon tibial components after two years assessed by means of RSA.


Secondary Outcome Measures:
  • The Objective is to Investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric Behaviour and Patient Outcome in a Prospective Randomized Clinical Trial. [ Time Frame: 3 months, 1, 2, 5, 7 and 10 years ] [ Designated as safety issue: Yes ]

    Plain radiographs for disease class. Clinical assessment AKSS and KOOS score. Post operative FU all plain radiographs for assessment of the component position.

    Yearly radiographic FU to assess wear, radiolucent zones and stress resorption and patella sky view projection.



Enrollment: 60
Study Start Date: February 2006
Estimated Study Completion Date: November 2016
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: February 16, 2007
Results First Received: September 29, 2015
Last Updated: April 6, 2016
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on August 23, 2016