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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon CR cemented | Active Comparator | Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented Peri-Apatite (PA) knee fixation and migration properties versus the cemented version. |
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| Triathlon CR uncemented | Active Comparator | Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented PA knee fixation and migration properties versus the cemented version. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon CR cemented | Device | Implantation of Knee Prosthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of patient outcome with radiographic analysis | Plain radiographs will be obtained for assessment of fixation of the device. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sören Toksvig-Larsen, MD | Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm | Hässleholm | Skåne County | 281 38 | Sweden |
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| Triathlon CR uncemented |
| Device |
Implantation of Knee Prosthesis |
|
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. |
| 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). | 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 | The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. | pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years |