Evaluation of Triathlon - a New Total Knee Prosthesis System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Stryker Nordic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stryker Nordic
ClinicalTrials.gov Identifier:
NCT00436982
First received: February 16, 2007
Last updated: December 6, 2007
Last verified: February 2007
  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 Phase
Total Knee Arthroplasty
Device: Triathlon Knee System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, RSA Series With 2-Years Follow-up.

Further study details as provided by Stryker Nordic:

Primary Outcome Measures:
  • Roentgen stereophotogrammetric analysis (RSA) [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plain radiographs for disease class.Clinical ass. KSS and KOOS score. Postop FU all plain radiographs for ass. of the component position. Yearly radiographic FU to assess wear, radiolucent zones and stress resorption and patella sky view projection. [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: December 2005
Estimated Study Completion Date: June 2010
Intervention Details:
    Device: Triathlon Knee System
    Orthopaedic implant
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients suffering exclusively from OA, Stage II-V [Ahlbäck, 1968 391] 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436982

Locations
Sweden
Hässleholm Hospital Recruiting
Hässleholm, Sweden
Contact: Sören Toksvig-Larsen, ass prof    +46746314304      
Contact: Anna S Pålsson, study nurse    +46451296051      
Sponsors and Collaborators
Stryker Nordic
Investigators
Principal Investigator: Sören Toksvig-Larsen, ass. prof Department of ortopaedics, Hässleholm Hospital
  More Information

No publications provided

Responsible Party: Sören Toksvig-Larsen, Hässleholms hospital
ClinicalTrials.gov Identifier: NCT00436982     History of Changes
Other Study ID Numbers: 20050705TRIATHLON RSA PROTOCOL
Study First Received: February 16, 2007
Last Updated: December 6, 2007
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Stryker Nordic:
Knee
Arthroplasty
Implant

ClinicalTrials.gov processed this record on August 28, 2014