From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Migration of glenoid component from baseline until 24 months
研究概览
简要总结
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
详细描述
Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. There's several ways to lateralize the glenoid component, a bone transplant placed underneath the glenoid component (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time. Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much comparative literature on metal vs. bony lateralization.
Patients with osteoarthritis and medialization of the glenoid articular surface, who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.
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)
盲法说明
Participants and health personnel examining the participants will be blinded. It will not be possible to blind the surgeons due to the nature of the intervention.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
- •massive glenoid medialization
- •Able to read or write Norwegian
排除标准
- •Severe osteoporosis
- •Osteonecrosis of the humeral head
- •Poor deltoid function
- •Revision surgery
- •Suspected chronic infection
- •Acute fracture
结局指标
主要结局
Migration of glenoid component from baseline until 24 months
时间窗: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.
CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation. The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner) CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.
次要结局
- Change in WOOS Index(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in Constant-Murley Score(Before randomization, 3, 12 and 24 months postoperatively.)
- Anchor Question 2(3, 12 and 24 months postoperatively)
- Change in range of motion(Before randomization, 3, 12 and 24 months postoperatively.)
- Anchor Question 1(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in Subjective Shoulder Value(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in EuroQol-5(Before randomization, 3, 12 and 24 months postoperatively.)