NL-OMON44724已完成不适用
Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty - ATTUNE
DePuy Synthes Joint Reconstruction, Inc.0 个研究点目标入组 208 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a) Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
- •b) Subject was diagnosed with NIDJD resulting from osteoarthritis (OA) or post-traumatic arthritis.
- •c) Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- •d) Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction (see Section 6.3.2).
- •e) Subject is currently not bedridden
- •f) Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
- •g) Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the PROs in the CIP in either Dutch or English translations.
排除标准
- •a) The Subject is a woman who is pregnant or lactating.
- •b) Contralateral knee has already been enrolled in this study.
- •c) Subject had a contralateral amputation.
- •d) Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- •e) Subject is currently experiencing radicular pain from the spine that radiates into the limb to receive TKA.
- •f) Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- •g) Subject is currently involved in any personal injury litigation, medical-legal or worker*s compensation claims.
- •h) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- •i) Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- •j) Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
- •k) Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- •l) Subject has a medical condition with less than 3 years of life expectancy.
研究者
相似试验
尚未招募
Unknown
Prospective multi-center postoperative outcomes cohort study in femoral trochanteric fracturesFemoral trochanteric fractureJPRN-UMIN000051818Sendai Tokushukai Hospital140
已完成
不适用
Evaluation of Post-Operative Recovery in ATTUNE® Total Knee ArthroplastyNon-inflammatory Degenerative Joint DiseaseNCT02339610DePuy Orthopaedics200
招募中
不适用
Assessing the post-operative quality of recovery and chronic pain rates after elective shoulder surgeryshoulder surgery functional outcomesMusculoskeletal - Other muscular and skeletal disordersAnaesthesiology - AnaestheticsACTRN12616000878471Dr Alwin Chuan250
尚未招募
1 期
A multi-center clinical study of a postoperative delirium prediction model and acupuncture pretreatment plan for elderly patients undergoing orthopedic surgery based on the combination of macroscopic appearance and microscopic indicatorsPostoperative DeliriumITMCTR2000003704Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
尚未招募
不适用
Multi-center cohort study on the postoperative outcomes of Discovery total elbow arthroplastyelbow arthropathyJPRN-UMIN000007738Kyoto University Hospital, Department of Orthopaedic Surgery50