Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 28
- 主要终点
- Constant Murley Score (CMS)
研究概览
简要总结
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
详细描述
There is one primary effectiveness endpoint and there are three primary safety endpoints:
-
Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
-
Primary safety endpoint(s):
-
No revision, removal, reoperation, supplemental fixation, or other intervention for any system component
-
No humeral or glenoid radiolucent line >2 mm is present in 50% or more zones at 2 years
-
No conclusive evidence of migration and tilt (>5mm migration and >10° tilt) of the humeral or glenoid component at 2 years
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
- •Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
- •Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes.
- •Individuals who are willing and able to return for follow-up as specified by the study protocol.
- •Individuals who are a minimum age of 22 years at the time of consent.
- •Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.
排除标准
- •BMI > 40 kg/m2
- •Individuals have active, uncontrolled local infection or systemic infection.
- •Patients who have not reached skeletal maturity, regardless of age.
- •Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).
- •Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
- •Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
- •Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
- •Revision of a failed hemi, total or reverse shoulder arthroplasty.
- •Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
- •Individuals who are bedridden per the Investigator's determination.
- •Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- •Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- •Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders).
- •Patient has a medical condition with less than 2 years life expectancy.
- •Patients who are known to be pregnant or breastfeeding.
- •Known polyethylene and/or metal sensitivity or allergy.
- •Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
- •Otherwise determined by the investigator to be medically unsuitable for participation in this study
- •Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)
研究组 & 干预措施
INHANCE Stemless Reverse
INHANCE(TM) Stemless Reverse Total Shoulder
干预措施: Reverse Total Shoulder (Device)
INHANCE Stemmed Reverse
INHANCE(TM) Stemmed Reverse Total Shoulder
干预措施: Reverse Total Shoulder (Device)
结局指标
主要结局
Constant Murley Score (CMS)
时间窗: Pre-op, 2 years
Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score.
Revision of any system component
时间窗: 2 year
No revision of any system component
Migration and Tilt (Humeral & Glenoid)
时间窗: 2 year
No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component
Reoperation of any system component
时间窗: 2 year
No reoperation of any system component
Supplemental Fixation of any system component
时间窗: 2 year
No supplemental fixation of any system component
Removal of any system component
时间窗: 2 year
No removal of any system component
Radiolucent Lines (Humeral & Glenoid)
时间窗: 2 year
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
次要结局
- Single Assessment Numeric Evaluation (SANE) Score(Pre-op, 3-month, 6-month, 1 year, 2 year)
- Survivorship(2 year)
- Complications(2 year)
- EQ-5D-5L and EQ-VAS(Pre-op, 3-month, 6-month, 1 year, 2 year)
- Constant Murley Score (CMS)(Pre-op, 3-month, 6-month, 1 year, 2 year)
- Simple Shoulder Test(Pre-op, 3-month, 6-month, 1 year, 2 year)