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临床试验/DRKS00032695
DRKS00032695招募中Unknown

Implementation of a new treatment scheme for primary knee prosthesis implantations in the German health care system in collaboration with DRV

Medizinische Hochschule Hannover0 个研究点目标入组 70 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • Indication for primary implantation of a total knee joint endoprosthesis
  • - Age: 18 - 80 years
  • - Patient is gainfully employed

排除标准

  • - ASA 3-6
  • - BMI > 34 kg/m2
  • - Diabetes mellitus with blood glucose imbalances (hypoglycemias)
  • - Chronic renal insufficiency with GFR < 60 (stage III according to NKF)
  • - Coronary artery disease with Z.n. intervention within the last 2 years or further complaints
  • - Permanent anticoagulation with heart valve replacement
  • - Dementia or other neurological diseases with alteration of gait (Parkinson's syndrome, myasthenia gravis, visual pathway disorders, etc.)
  • - Anemia/hemophilia/thrombophilia with secondary DVT/LAE
  • - Known depression/psychoaffective disorder
  • - Chronic pain patient with long-term opioid medication/fibromyalgia
  • - Rheumatoid arthritis with expected limitation in postoperative mobilization
  • - COPD with limitations in daily living/sleep apnea syndrome
  • - Massive ROM deficit
  • - Lack of compliance for complex treatment procedures
  • - Language barrier
  • Subsequent exclusion from clinical trial:
  • - Loss of assignment to OptiTrack Athletic group and continued treatment according to standard (time: until discharge).

研究者

发起方
Medizinische Hochschule Hannover

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