Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
The goal of this observational study is to collect clinical and radiological data to monitor the safety and performance of the ROMAX hip resurfacing system. The main parameter that will be measured is the rate of revisions at 10 years.
详细描述
This single-center, post-market, prospective, longitudinal, and uncontrolled cohort study aims to evaluate the survival rate of the Medacta ROMAX hip resurfacing system, particularly focusing on dislocations and the potential consequences of wear over a 10-year period. Additionally, the study will assess clinical performance through patient-reported outcomes (PROMs) and analyze the migration behavior of the device using the CTMA method in a subgroup of 40 patients. The study will include a total of 150 cases, with 40 patients undergoing CTMA analysis at 3 years post-surgery. Eligible patients will be informed during preoperative visits and included upon signing the consent form, prior to surgery. Participation in the CTMA subgroup is optional and does not affect overall study inclusion. Follow-ups will be conducted at 3 months, 1, 3, 5, and 10 years. Data collection will include clinical scores, clinical and radiological data related to preoperative and postoperative status, and perioperative surgical details.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use.
- •Aged between 18 and 65 years at the time of surgery.
- •Ability and willingness to provide written informed consent for participation.
排除标准
- •Active infection
- •BMI > 40
- •Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams.
- •Significantly deformed anatomy (at the surgeon's discretion)
- •Osteomalacia where the fixation of an uncemented implant is contraindicated
- •Active rheumatoid arthritis
- •Osteoporosis
- •Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated
- •Muscle atrophy or neuromuscular disease
- •Known allergy or hypersensitivity to the implant material
- •Any patient who cannot or does not wish to give informed consent to participate in the study
- •Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.
结局指标
主要结局
Implant survival
时间窗: 10 years
Survival of the implant through Kaplan-Meier analysis based on revisions
次要结局
- Forgotten Joint Score (FJS)(3 months, 1 year, 3 years, 5 years, 10 years)
- Oxford Hip Score (OHS)(3 months, 1 year, 3 years, 5 years, 10 years)
- Radiologic Evaluation(3 months, 1 year, 3 years, 5 years, 10 years)
- Harris Hip Score (HHS)(3 months, 1 year, 3 years, 5 years, 10 years)
- CT-micromotion analysis (CTMA)(3 months, 1 year, 3 years)
- Postel-Merle d'Aubigné Score (PMA)(3 months, 1 year, 3 years, 5 years, 10 years)
- UCLA Activity Scale(3 months, 1 year, 3 years, 5 years, 10 years)
- HOOS (Hip injury and Osteoarthritis Outcome Score) Symptoms subscale(3 months, 1 year, 3 years, 5 years, 10 years)