Assessment of Preoperative and Postoperative Ankle Kinematics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Roentgenstereophotogrammetric analysis
研究概览
简要总结
The objective is to study the joint kinematics of the prosthetic implant, in terms of translation, rotation, Range of motion and proprioception, in patients treated for prosthetic replacement of the ankle, quantitatively and under physiological load conditions.
详细描述
Patients will be subjected to the same tests at zero time and 9 months after the implantation of the prosthesis, except for RSA which will be performed only 9 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for ankle prosthesis
- •Potential party able to provide informed consent and sign the approved Informed Consent Form;
- •Male or female patients aged 40 to 80;
- •Patients available to perform post-operative rehabilitation according to standard protocol, follow-up visits and radiological investigations scheduled for follow-up up up up to 24 months. In addition, patients who are available to perform all study tests, preoperators and follow-up.
排除标准
- •Previous total prosthetic replacement of the ankle (revision surgery);
- •Severe pre-operative deformity in valgus or varus (>10 sanguine); BMI>40 kg/m2;
- •Pre-existing abnormalities of walking kinematics (amputations, neuro-muscular diseases, polio, hip dysplasia);
- •Severe arthrosis of the knee (Kellgren-Lawrence>3);
- •Severa coxartrosi (Kellgren-Lawrence>3);
- •Previous hip and/or knee prosthesis surgery;
- •Total avascular astragalus necrosis or other severe bone loss of the ankle that makes the implantation of standard prosthetic components contraindicated;
- •Pregnancy confirmed by positive hcg serum or in vitro diagnostic test or ongoing breastfeeding;
- •Active or latent infection of the affected ankle joint or any other systemic infection being treated;
- •History of alcoholism, drug or substance abuse intravenously, psychosis, personality disorder/s, poor motivation, emotional or intellectual problems that could make the potential subject unstable for participation in the trial, or any combination of variables which in the opinion of the Principal Investigator should exclude the potential subject;
- •Clinically documented acute or chronic pathology, other than the indication for the treatment adopted in this Trial, which could affect life expectancy or make it difficult to interpret the outcome of the potential subject in accordance with the Protocol (e.g., renal, hepatic, cardiac, endocrine, haematological, autoimmune, bone metabolism, crystal deposits or neoplasms);
- •Potential subjects with medical conditions that interfere with the ability to participate in a standardized rehabilitation program;
- •Participation in any other trial of another drug or experimental device within 60 days prior to the screening visit or administration of that drug or device during the course of this trial.
结局指标
主要结局
Roentgenstereophotogrammetric analysis
时间窗: 9 months
Roentgenstereophotogrammetric analysis (RSA) is a radiographic technique, highly accurate both to assess the primary stability of the implant, and therefore the micromovements between bone and prosthetic implant, and for the evaluation of the kinematics of the prosthetic components. Using reference points it is possible to measure the micro-movements that occur between several contiguous elements
次要结局
- modified Star Excursional Balance Test (mSEBT) functional test(9 months)
- evaluation of range of motion (degree)(9 months)
- Delos Postural Proprioceptive System(9 months)
- American Orthopaedic Foot & Ankle score (AOFAs) questionnaire(9 months)
- Short Form Health Survey - 12 questionnaire(9 months)
研究者
Massimiliano Mosca
Principal Investigator
Istituto Ortopedico Rizzoli