Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Passive range of motion
研究概览
简要总结
The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.
详细描述
A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty
- •No history of prior shoulder arthroplasty
- •Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)
- •Ability to speak, read and write English
排除标准
- •Any impairment that would prevent answering the surveys
- •No children or adolescents under the age of 18 years old
- •No prisoners, pregnant women, or mentally disabled persons
- •No Workers' Compensation cases
研究组 & 干预措施
32mm Glenosphere
The control group will receive the standard 32mm glenosphere.
干预措施: Glenosphere size for Reverse Shoulder Arthroplasty (Device)
36mm Glenosphere
The experimental group will receive a 36mm glenosphere.
干预措施: Glenosphere size for Reverse Shoulder Arthroplasty (Device)
结局指标
主要结局
Passive range of motion
时间窗: Change from baseline (pre-operative) to 2 years follow-up
Shoulder elevation and external rotation
Active range of motion
时间窗: Change from baseline (pre-operative) to 2 years follow-up
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
次要结局
- American Shoulder and Elbow Surgeon (ASES) Shoulder Index(Change from baseline (pre-operative) to 2 years follow-up)
- Constant-Murley Shoulder Outcome score(Change from baseline (pre-operative) to 2 years follow-up)