DRKS00034598尚未招募3 期
Multicentric, randomised, prospective trial to assess the efficacy and safety of a novel stemless reverse shoulder system
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Conservative therapy options have been exhausted
- •Clinical and radiological (Rx or Ct or MRT) indication for reverse total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis and/or cuff tear arthropathy/insufficient rotator cuff
- •Functional deltoid muscle
- •Willingness and ability to comply with study protocol
排除标准
- •Clinical and radiological (Rx or Ct or MRT) indication for anatomic total shoulder replacement
- •Medical condition or balance impairment that could lead to falls
- •Lack of sufficient-quality bone to seat and support implant
- •Patients with metaphyseal cysts, osteopenia, osteoporosis, or other metabolic bone diseases, or in cases with fractures in the metaphyseal area that disturb adequate primary implant stability and secondary fixation
- •Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcome
- •Hemiplegia on the affected side
- •Arm plexus affection on the affected side
- •Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
- •Active metastatic or neoplastic disease at the shoulder joint
- •Chemotherapy treatment/radiotherapy within 6 mo before surgery
- •>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
- •Pregnancy or plan to become pregnant during study period
- •Inability to understand study or a history of noncompliance with medical advice
- •Current enrolment in any clinical research study that might interfere with this study
- •Known metal allergies or sensitivity.
- •Previous or actual infection at or near the site of implantation.
- •Previous or actual distant or systemic infection
- •Previous inclusion of the patient in the current study because of the controlateral shoulder
- •Lack of sufficient-quality bone to seat and support the metaphyseal humeral implant
研究者
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