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 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 cemented vs. uncemented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Implantation of Knee Prosthesis
Implantation of Knee Prosthesis
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Skåne County, Sweden
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric as a predictor of late mechanical loosening.
Time frame: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes
Investigation of patient outcome with radiographic analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Time frame: 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with Knee Society Score (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (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.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living, function in sport and recreation 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).
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
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The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years