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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 Standard vs. Short Keel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon Standard Keel | Active Comparator | Triathlon Cruciate Retaining knee (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel. |
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| Triathlon Short Keel | Active Comparator | Triathlon Cruciate Retaining knee (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon Standard Keel | Device | Implantation of Knee Prosthesis |
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| 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 |
| 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 |
| Investigation of clinical performance and patient outcome with KSS (Knee Society Score) |
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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 |
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| Triathlon Short Keel |
| Device |
Implantation of Knee Prosthesis |
|
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, 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 |
| Investigation of clinical performance and patient outcome with KOOS patient questionnaire | KOOS (Knee injury and osteoarthritis outcome score) 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 |
| Investigation of clinical performance and patient outcome with EQ-5D patient questionnaire | The EQ-5D (EuroQuol-5 dimension) 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 |