NL-OMON56814尚未招募不适用
A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation - TSA with Exactech with GPS or conventional instrumentation: an RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is at least 21 years of age at the time of surgery.
- •Patient is indicated for reverse shoulder arthroplasty.
- •Patient is willing to participate by complying with pre- and postoperative
- •visit requirements.
- •Patient is willing to participate for the entire length of the prescribed
- •follow-up (minimum 2 years).
- •Patient is willing and able to review and sign a study informed consent form.
- •Preop CT scan is within 3 months of the date of surgery.
排除标准
- •Revision shoulder arthroplasty.
- •Reverse shoulder arthroplasty for fracture.
- •Need for structural glenoid bone graft.
- •Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a
- •secondary remote infection is suspected or confirmed, implementation should be
- •delayed until infection is resolved.
- •Inadequate or malformed bone that precludes adequate support or fixation of the
- •prosthesis.
- •Neuromuscular disorders that do not allow control of the joint.
- •Significant injury to the brachial plexus.
- •Non-functional deltoid muscles.
- •The patient is unwilling or unable to comply with the post-operative care
- •instructions.
研究者
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