NCT00436982已完成不适用
Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Roentgen Stereophotogrammetric Analysis (RSA)
研究概览
简要总结
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.
详细描述
The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering exclusively from osteo arthritis (OA), Stage II-V [Ahlbäck, 1968] 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.
排除标准
- •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).
结局指标
主要结局
Roentgen Stereophotogrammetric Analysis (RSA)
时间窗: 2 years
To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.
次要结局
- Blood Loss(intra-operative)
- Duration Hospital Stay(preoperative to discharge)
- Roentgen Stereophotogrammetric Analysis (RSA)(3 months, 1, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)([Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years])
- Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Mean Operative Time(intra-operative)
研究者
研究点 (1)
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