NCT02414542已完成不适用
A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- UCLA activity score
研究概览
简要总结
Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Age ≥ 18 years old
- •Life expectancy over 5 years
- •Ambulatory patients
- •Painful primary coxarthrosis
- •Painful secondary coxarthrosis
- •Avascular necrosis
- •Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits
- •Signed study-specific Informed Consent Form
排除标准
- •Body mass index over 28 kg/m2 for the modular version
- •Requiring revision of previous standard femoral stem
- •Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator
- •Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS< 60 points
- •Significant proven or suspicious infection of the target hip
- •Any serious infectious disease before the study according to the Investigator
- •Muscular insufficiency that may compromise functional recovery
- •Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator
- •Known or suspicious hypersensitivity to the metal of the implant
- •Recurrent medical history of immune-mediated reactions or other systemic immune disorders
- •Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator
- •Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit
- •Previous organ transplant
- •Any intercurrent chronic disease or condition that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation
- •Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition
- •Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- •Current alcoholism, and/or any known current addiction to pain medications or drugs
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study
- •Participation in any experimental drug/device study within the 6 months prior to the preoperative visit
- •Unwillingness or inability to comply with rehabilitation and to return for follow-up visits
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
结局指标
主要结局
UCLA activity score
时间窗: 24 months
Range of motion (ROM)
时间窗: 24 months
Time up and go test (TUG)
时间窗: 24 months
Harris Hip Score (HHS)
时间窗: 24 months
次要结局
- Hip disability and Osteoarthritis Outcome Score (HOOS)(24 months)
- Implant stability measured by radiographic evaluations(24 months)
- Revision rate(24 months)
- Incidence of device-related Adverse Events/Serious Adverse Events(24 months)
研究者
研究点 (1)
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