NCT07812324尚未招募不适用
Randomized, Controlled, Multi-center, Prospective Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
Medacta USA12 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
- 试验地点
- 12
- 主要终点
- This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
研究概览
简要总结
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject 22 years or older
- •Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis.
- •Scapula and proximal humerus must have reached skeletal maturity
- •Willing and able to comply with the protocol
- •Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
排除标准
- •Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as:
- •Rapid joint destruction, marked bone loss or bone resorption;
- •Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
- •Osteomalacia
- •osteoporosis
- •rheumatoid arthritis
- •Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
- •Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
- •Infection at or near the site of implantation, including:
- •Glenohumeral joint infection
- •Osteomyelitis
- •Distant or systemic infection
- •Medical conditions or balance impairments that could lead to falls
- •Prior Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
- •Prior failed rotator cuff surgery, but excluding successful shoulder arthroscopy
- •Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
- •Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
- •Metabolic disorders which may impair bone function
- •Nonfunctional deltoid muscle
- •Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
- •Patients diagnosed with severe shoulder instability
- •Patients diagnosed with subscapularis incompetence
- •Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
- •Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
- •Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery or patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
- •Female subjects who are pregnant or planning to become pregnant within the study period
- •In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
- •History of any cognitive or mental health status that would interfere with study participation
- •Substance Use Disorder (alcohol and/or drug)
- •Engages in manual labor or sports activities that could affect shoulder outcome
- •Patients who have a work-related injury leading to shoulder OA
- •Currently enrolled in any clinical research study that might interfere with the current study endpoints
- •Patients with a life expectancy of less than three years
- •Medical condition or balance impairment that could lead to falls
- •Weight bearing shoulder due to wheelchair, crutches, rollator at the time of operation
- •Individuals who are incarcerated or detained in a correctional facility or under any form of legal supervision that limits their ability to voluntarily consent to participate in the trial.
- •Previous randomization of the subject in the current study.
研究组 & 干预措施
143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational)
Experimental
干预措施: Mirror Anatomic Total Shoulder Prosthesis (Device)
143 patients undergoing implantation of Medacta Anatomic Shoulder (control)
Active Comparator
干预措施: Medacta Anatomic Shoulder (Device)
结局指标
主要结局
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
时间窗: 24 months of follow up
The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations.
次要结局
- Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.(24 Months of follow up)
研究者
研究点 (12)
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