Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented

Study Overview
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Brief Summary
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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.

Detailed Description
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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 evaluation is carried out by a prospective randomised RSA-study with Triathlon CR cemented vs. uncemented.

Official Title
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Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining (CR) - Cemented vs. Uncemented

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Triathlon CR cemented
* Device: Triathlon CR uncemented


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering exclusively from osteo arthritis, Stage II-V [Ahlbäck Trauma Score, 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. 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. Patients with other severe concurrent joint involvements, which can affect their outcome. 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. Patients under the protection of law (e.g. guardianship).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triathlon CR cemented<br>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. | Device: Triathlon CR cemented<br>* Implantation of Knee Prosthesis<br>|
| Active Comparator: Triathlon CR uncemented<br>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. | Device: Triathlon CR uncemented<br>* Implantation of Knee Prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |