Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis Triathlon CR vs. PS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty, Replacement, Knee
- Sponsor
- Stryker Orthopaedics
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
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 CR vs. Triathlon PS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck, 1968 391\] 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.
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Time Frame: 2 years follow-up
Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.
Secondary Outcomes
- Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire(1, 2, 5, 7 and 10 years)
- Investigation of Patient Outcome With Radiographic Analysis(3 months, 1, 2, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)