Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
研究概览
简要总结
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.
详细描述
The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.
Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.
In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B&C.
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
- Single (Participant)
盲法说明
non information of the type of implant used is given to the patient
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B&C. Radiological confirmed
排除标准
- •other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),
结局指标
主要结局
The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
时间窗: one years follow up (FU)
All participants are assessed with online questionnaire, Patient Related Outcome Measurement (PROM) 0-100% (100% best), validated
次要结局
- x-rays(one and two years FU)
- Constant Murley score(one and two years FU)
- Subjective shoulder Volume (SSV)(one and two years FU)
研究者
Klaus Wilhelm Josef Hanisch
Principal Investigator
University of Southern Denmark