Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit

Launched by STRYKER ORTHOPAEDICS · Jun 23, 2017

Keywords

ClinConnect 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.

The evaluation is carried out by a prospective randomised RSA-study with Triathlon PA vs. Triathlon Pressfit

Gender

ALL

Eligibility 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).