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出境医 / 临床实验 / G7双迁移率系统用于总髋关节置换术,用于治疗股骨颈部骨折

G7双迁移率系统用于总髋关节置换术,用于治疗股骨颈部骨折

研究描述
简要摘要:
这是一项回顾性,前瞻性,多中心,非舒张后的,后的后临床随访研究,涉及掌握THA的骨科外科医生,并经历了本研究中包含的设备的植入。

病情或疾病 干预/治疗
髋部骨折设备:G7髋臼系统

详细说明:
该研究的目的是通过分析标准评分系统,X光片,修订和不良事件记录来记录G7双迁移率系统的性能和安全性。最多包括15个中心和最多300个植入臀部。每个中心最多可以注册40个臀部,以允许各种研究人员和临床环境的结局一致性
学习规划
研究信息的布局表
研究类型观察
估计入学人数 300名参与者
观察模型:其他
时间观点:其他
官方标题:回顾性和前瞻性多中心结果研究用于治疗股骨颈部骨折的全髋关节置换术中的G7双迁移率系统
实际学习开始日期 2020年1月1日
估计的初级完成日期 2027年12月
估计 学习完成日期 2028年3月
武器和干预措施
组/队列 干预/治疗
G7 G7髋臼系统
所有患者将接受G7 G7髋臼系统
设备:G7髋臼系统
所有患者将接受G7髋臼系统

结果措施
主要结果指标
  1. 植入物脱位率[时间范围:手术后一年]
    脱位定义为两个人造关节组件之间的关节接触完全丧失。


次要结果度量
  1. 牛津髋关节评分的疼痛和功能性能[时间范围:手术后最多5年]
    牛津髋关节评分由12个特定于疾病的问题组成,这些问题测量了患者报告的疼痛和髋关节功能。对每个问题的回答是为5点李克特量表的格式化,从0(最坏的结果 /大多数症状)到4(最佳结果 /最少症状)。每个问题的分数都添加在一起,以在0到48之间的最终结果。

  2. 通过修订率植入生存率[时间范围:最多5年,手术后5年]
    使用Kaplan-Meier分析的累积存活率。

  3. EQ-5D-5L问卷调查的生活质量[时间范围:手术后最多5年]
    这个5级EQ-5D版本(EQ-5D-5L)由2页组成:EQ-5D描述系统和EQ Visual Aneogue量表(EQ VAS)。描述性系统包括五个维度:流动性,自我保健,通常的活动,疼痛/不适和焦虑/抑郁。每个维度有5个级别:没有问题,小问题,中度问题,严重的问题和极端问题。 1位数字表示为该维度选择的级别。五个维度的数字可以合并为一个描述患者健康状态的5位数字。健康状态可以转换为单个指数值,其中1代表完全健康,0代表死亡。 EQ VAS以垂直视觉模拟量表记录了患者的自我评估健康状况,其中端点被标记为“您可以想象的最佳健康”和“您能想象的最糟糕的健康”。

  4. JHEQ的生活质量[时间范围:手术后最多5年]
    日本骨科协会髋关节疾病评估问卷(JHEQ)是一项自我管理的问卷,可评估髋关节疾病患者的生活质量。问卷由三个子量表组成:疼痛(28分),运动(28分)和心理(28分),得分较高,表明结果更好。该测量仅适用于日本人口。

  5. JOA髋关节得分的疼痛和功能性能[时间范围:手术后最多5年]
    日本骨科协会(JOA)臀部分数包括四个子类别:疼痛(疼痛,40分),运动范围(ROM,20分),步行能力(步态,20分)和日常生活的活动(ADL,ADL, 20分),得分较高,表明结果更好。该测量仅适用于日本人口。

  6. 报告的不良事件报告[时间范围:手术后5年]
    按类别,发射率和频率分类的不良事件摘要


资格标准
有资格信息的布局表
有资格学习的年龄: 55年至80年(成人,老年人)
有资格学习的男女:全部
采样方法:概率样本
研究人群
研究人群将由需要主要THA治疗股骨颈部骨折的患者组成,并满足本节概述的资格标准。为了避免潜在的选择偏见,每个研究者将使用G7双移动性系统为每位连续的符合条件的患者提供研究参与。
标准

纳入标准:

  • 55至80岁,包括
  • 骨骼成熟
  • 接受治疗或需要初级治疗非工会,股骨颈部骨折,其他技术无法控制
  • 植入了G7双迁移率系统或决定植入G7双迁移率系统的决定是独立并在招募研究之前进行的
  • 愿意并且能够按照研究协议所述完成计划的后续评估
  • 已经参加了知情同意程序,并愿意并且能够签署IRB/EC批准的知情同意书

排除标准:

  • 是败血症,有活性感染或在受影响的关节上患有骨髓炎
  • 通过治疗外科医生定义的明显骨质疏松症
  • 具有代谢障碍,可能会损害骨骼的形成
  • 有骨乳核
  • 具有远处的感染灶,可能会传播到植入物部位
  • 具有快速的关节破坏,在术前X光片上明显的骨质流失或骨吸收
  • 在植入物部位或神经肌肉疾病的血管不足,肌肉萎缩,可能危及手术的结果
  • 有任何伴随疾病,可能会危害植入物的功能或成功
  • 已知怀孕
  • 是囚犯,已知的酗酒或毒品滥用者或精神上无能或无法理解该研究的参与需要什么
  • 对一个或多个的敏感或过敏
联系人和位置

联系人
位置联系人的布局表
联系人:Irene Chong +65 6854 EXT 7256 irene.chong@zimmerbiomet.com

位置
布局表以获取位置信息
韩国,共和国
首尔国立大学医院尚未招募
韩国首尔,共和国,03080
联系人:Jeong Joon Yoo 82-10-2281-6558 jjyos@snu.ac.kr
首席调查员:郑琼Yoo
汉阳大学医学中心尚未招募
韩国首尔,共和国,04763
联系人:Yeesuk Kim 82-10-7371-7372 Estone96@daum.net
首席研究员:Yeesuk Kim
阿桑医疗中心招募
韩国首尔,共和国,05505
联系人:PIL WHAN YOON 82230103535 orthoon@amc.seoul.kr
首席调查员:PIL WHAN YOON
首尔国立大学邦丹医院尚未招募
韩国首尔,共和国,05505
联系人:Young Kyun Lee 82-10-9090-2468 ykleemd@gmail.com
首席调查员:年轻的Kyun Lee
三星医疗中心尚未招募
韩国首尔,共和国,06351
联系人:Seung Jae Lim 82-10-9933-6707 Seungjae.lim@samsung.com
首席研究员:Seung Jae Lim
首尔圣玛丽医院尚未招募
韩国首尔,共和国,06591
联系人:Young Wook Lim 82-10-9570-5860 albire00@naver.com
首席研究员:Young Wook Lim
Kyunghee大学医学中心尚未招募
韩国首尔,共和国,130-872
联系人:kee hyung rhyu khrhyu@empas.com
首席研究员:Kee Hyung Rhyu
赞助商和合作者
Zimmer Biomet
调查人员
调查员信息的布局表
首席研究员: Kee-Hyung Rhyu Kyunghee大学医学中心
Tracking Information
First Submitted Date July 4, 2019
First Posted Date July 24, 2019
Last Update Posted Date July 2, 2020
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2019)
Implant dislocation rate [ Time Frame: One year post-surgery ]
Dislocation is defined as the complete loss of articulation contact between two artificial joint components.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 21, 2019)
  • Pain and Functional Performance by Oxford Hip Score [ Time Frame: Up to 5 years post-surgery ]
    The Oxford Hip score consist of 12 disease-specific questions measuring patient-reported pain and function of the hip joint. Responses to each question are formatted as a 5-point Likert scale, scored from 0 (the worst outcome/most symptoms) to 4 (the best outcome / least symptoms). The scores for each question are added together for a final result between 0 and 48.
  • Implant survivorship by revision rates [ Time Frame: Up to 5 years post-surgery ]
    Cumulative survival rates using a Kaplan-Meier analysis.
  • Quality of life by EQ-5D-5L questionnaire [ Time Frame: Up to 5 years post-surgery ]
    This 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The health states may be converted into a single index value where 1 represents full health and 0 represents death. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
  • Quality of life by JHEQ [ Time Frame: Up to 5 years post-surgery ]
    The Japanese Orthopaedic Association hip disease evaluation questionnaire (JHEQ) is a self-administered questionnaire that evaluates the quality of life in patients with hip disease. The questionnaire consists of three subscales: pain (28 points), movement (28 points), and mental (28 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.
  • Pain and Functional Performance by JOA Hip Score [ Time Frame: Up to 5 years post-surgery ]
    The Japanese Orthopaedic Association (JOA) hip score consists of four subcategories: pain (Pain, 40 points), range of motion (ROM, 20 points), ability to walk (Gait, 20 points), and activities of daily life (ADL, 20 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.
  • Adverse events reported [ Time Frame: Up to 5 years post-surgery ]
    Summary of adverse events by category, incidence and frequency
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
Official Title Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
Brief Summary This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
Detailed Description The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.
Condition Hip Fractures
Intervention Device: G7 Acetabular System
All patients will receive G7 Acetabular System
Study Groups/Cohorts G7 G7 Acetabular System
All patients will receive G7 G7 Acetabular System
Intervention: Device: G7 Acetabular System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 21, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2028
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 55 to 80 years of age, inclusive
  • Skeletally mature
  • Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
  • Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
  • Willing and able to complete scheduled follow-up evaluations as described in the study protocol
  • Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion Criteria:

  • Is septic, has an active infection or has osteomyelitis at the affected joint
  • Has significant osteoporosis as defined by treating surgeon
  • Has metabolic disorder(s) which may impair bone formation
  • Has osteomalacia
  • Has distant foci of infections which may spread to the implant site
  • Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
  • Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
  • Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
  • Is known to be pregnant
  • Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
  • Has a known sensitively or allergy to one or more of
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Irene Chong +65 6854 ext 7256 irene.chong@zimmerbiomet.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04031209
Other Study ID Numbers CSA2019-02H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Principal Investigator: Kee-Hyung Rhyu Kyunghee University Medical Center
PRS Account Zimmer Biomet
Verification Date June 2020