NCT06371833招募中不适用
A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
Limacorporate S.p.a2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of Costant Murley Score (CS)
研究概览
简要总结
This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years old;
- •Full skeletal maturity;
- •Life expectancy over 24 months;
- •Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;
- •Patient meets at least one of the following indications:
- •For Anatomic configuration:
- •non-inflammatory degenerative joint disease (i.e., osteoarthritis);
- •inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
- •avascular necrosis of the humeral head;
- •cuff tear arthropathy (CTA Heads only);
- •For Reverse configuration:
- •rotator cuff tear arthropathy;
- •osteoarthritiswith rotator cuff tear;
- •rheumatoid arthritis with rotator cuff tear;
- •massive irreparable rotator cuff tear;
- •Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
- •Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.
排除标准
- •Patients who lack capacity to be able to provide informed consent to participate in the study.
- •Local or systemic general infection;
- •Septicaemia;
- •Persistent acute or chronic local or systemic osteomyelitis;
- •Confirmed neurologic lesion compromising shoulder joint function;
- •Deltoid muscle insufficiency;
- •Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);
- •Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;
- •Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;
- •Proximal humerus fracture sequelae with inadequate bone stock;
- •Vascular or nerve diseases affecting the concerned limb;
- •Metabolic disorders which may impair fixation and stability of the implant;
- •Any concomitant disease that might affect the implanted prosthesis;
- •Metal hypersensitivity to implant materials (CoCrMo);
- •Patient with significant renal impairment;
- •Lower mobility issues that may affect the study evaluation;
- •Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;
- •Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.
研究组 & 干预措施
Adult patients requiring a primary TSA or RSA
Device: PRIMA humeral stem in anatomic or reverse configuration Shoulder arthroplasty according to the instruction for use.
干预措施: Shoulder Arthroplasy with PRIMA humeral stem (Device)
结局指标
主要结局
Changes of Costant Murley Score (CS)
时间窗: From preoperative (baseline) to 24-month follow-up.
The primary endpoint is to assess the change of Constant Murley Score (CS). Constant score (CS) is a clinical method of shoulder functional assessment that allows individual-parameter assessments to be combined with an overall 100-point scoring system. The final result is graded, with the normalized 100-point shoulder score, as excellent (85 to 100 points), good (71 to 84 points), fair (56-70), poor (0-55). The weighted Constant score is calculated as a percentage of norm
次要结局
- Changes in the American Shoudler and Elbow Surgeons (ASES) score(From preoperative (baseline) to 24-month follow-up.)
- Changes in Range of Motion measures(From preoperative (baseline) to 24-month follow-up.)
- Radiographic stability of the humeral component(From immediate postoperative (baseline) to 24-months follow-up)
- Survival rate (Kaplan-Meier estimate)(From immediate post-operative to 24-months follow-up.)
- Incidence, type and severity of Adverse Events and Adverse Device Effects(From surgery to 24-months follow-up.)
研究者
研究点 (2)
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