CTRI/2012/02/002457尚未招募4 期
A Double-blinded Randomised Controlled Trial Comparing the Performance of the Sigma® CR150 and Sigma® CR Knee Systems, When Used in Fixed and Mobile Bearing Primary Cruciate Retaining Total Knee Arthroplasty for the Treatment of Osteoarthritis
DePuy International0 个研究点目标入组 402 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 402
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Inclusion Criteria:
- •i)Male or female subjects, aged between 50 and 75 years inclusive.
- •ii)Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •iv) Subjects defined by the Investigator as ASA Grade I or II.
- •v) Subjects with a primary diagnosis of osteoarthritis.
- •vi) Subjects who require a primary total knee arthroplasty.
- •vii) Subjects who can achieve active flexion of 90 degrees.
排除标准
- •i) Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •ii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •iii) Subjects who have participated in a clinical investigation with an investigational product in the last month.
- •iv) Subjects who are currently involved in any injury litigation claims.
- •v) Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
- •vi) Subjects with a fixed flexion deformity of over 20 degrees.
- •vii) Subjects with recurvatum (definition: hyperextension >= 5 degrees).
- •viii) Subjects who cannot flex their hip to 90 degrees.
- •ix) Subjects with a BMI of 35 or above.
- •x) Subjects defined by the Investigator as ASA Grade III-V.
- •xi) Subjects who are identified pre-operatively as having bone defects which require augmentation.
- •xii) Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the knee joint.
- •xiii) Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
- •xiv) Subjects who have undergone contralateral total knee arthroplasty during the previous 6 months.
- •xv) Subjects who in the opinion of the Investigator require patellar resurfacing.
- •Intra-operative exclusion criteria:
- •i) Subjects who have uncontained bone defects or defects bigger than 8 mm3 and/or require augmentation.
- •ii) Subjects who are not suitable to receive both the study and comparator devices.
- •iii) Subjects who require patellar resurfacing
研究者
相似试验
已完成
4 期
Comparing Salivary Levels of TNF alpha in Patients with Oral Lichen Planus Treated with Topical Clobetasol Propionate and Fluocinolone Acetonidepatients with oral lichen planusOral Lichen Planus, Clobetasol Propionate, Fluocinolone Acetonide, Topical steroid,TNF alphaTCTR20220705003Faculty of Dentistry Chiang Mai university ,Chiang Mai, Thailand26
招募中
1 期
Intraoperative pillar corticosteroid injection Does it improve the patient satisfaction after carpal tunnel surgery? Randomized controlled trial, Double blind studyPillar corticosteroid injectionCarpal tunnel releasePillar painCarpal tunnel syndromeTCTR20211130003Chakrinaruebodindra medical institute84
Enrolling By Invitation
1 期
Efficacy of night splint position in Giovanni position compare with Traditional position on acute plantar fasciitis treatmentight splint is the treatment options in patient with acute plantar fasciitis that is not improve with conservative treatmentNight splint, traditional position, digiovanni position, fiberglass night splintTCTR20220310001Faculty of Medicine, Prince of Songkla University48
进行中（未招募）
1 期
Clinical Study Investigating Autologous Muscle-Derived Cells for treatment of Female Stress Urinary Incontinence PatientsFemale Stress Urinary IncontinenceMedDRA version: 18.1Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2014-002919-41-BECook MyoSite Incorporated627
进行中（未招募）
1 期
Clinical Study Investigating Autologous Muscle-Derived Cells for treatment of Female Stress Urinary Incontinence PatientsFemale Stress Urinary IncontinenceMedDRA version: 20.0Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2014-002919-41-DECook MyoSite Incorporated267