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临床试验/NCT07199751
NCT07199751招募中不适用

Vergleich Der Komplikationsrate, Des Funktionellen Outcomes Und Der Lebensqualität Zwischen Standard Therapie Versus Fast Track Therapie Bei Patienten Und Patientinnen Nach Hüft-TEP Operationen

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Hospital length of stay (days)

研究概览

简要总结

The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed.

The questionnaires will only be collected in the study: Eq-5d-5l, HOOS, self-efficacy, enjoyment of movement, fear of movement, pain catastrophizing.

详细描述

Around 400,000 hip and knee endoprostheses are implanted in Germany every year. Due to demographic change, the trend is clearly on the rise, which also results in rising costs in this area for the solidarity community. The Clinic for Orthopaedics and Sports Orthopaedics at the TUM Clinic is about to implement the Fast Track method after total hip arthroplasty (THA, in German: Hüft-TEP). The aim of this method is to shorten the length of stay in hospital and the post-operative recovery time as well as to promote rapid mobilization and independence of patients without worsening the functional outcome or the complication rate. The investigators will therefore investigate the extent to which it is possible to reduce the length of hospital stay without compromising function.

  • Primary endpoints: Hospital length of stay, HOOS.
  • Secondary endpoints: PROMs Quality of life Eq-5d-5l (EuroQol 5 dimensions Lang) Function Mobility (TUG test) in seconds Pain (NRS), ROM (neutral zero method), Strength (Nm/kg body weight, muscle function test) Self-efficacy/ pleasure/ fear of movement/pain catastrophizing Exercise self efficacy scale (ESES), physical activity enjoyment scale (PACES), Kinesiophobia (TSK), Pain catastrophizing scale (PCS).

With an original length of stay of 6 days and a target length of stay of 4 days, the expected reduction is 2 days. A standard deviation of 3 days is assumed in both groups (calculations based on patient data from August to December 2024) and a significance level of 0.05 and power of 80% are assumed. The required number of cases is therefore at least 36 participants per group. With this number of cases, the non-inferiority of the fast-track method compared to the standard method with regard to HOOS can also be demonstrated with a probability of 80%, assuming that the true mean difference between the methods is 0 points and the standard deviation for both methods is 15 points (Δ = 10 points, one-sided 97.5% confidence interval). To compensate for a potential drop-out rate, 45 patients per group should be recruited. With a primary hip TEP (THA) surgery rate of approx. 10 patients per week (cf. 2024) and a 2-month duration per group, the investigators can recruit a maximum of 80 patients per group. The investigators are therefore confident that the required case number of 45 per group will be reached.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • The patient will undergo surgery at Klinikum rechts der Isar, Technical University of Munich (TUM)
  • Written informed consent for participation in the study after detailed explanation of the nature, significance, risks and scope of the clinical trial
  • Written informed consent from the patient for data collection and data processing, with the patient fully informed.
  • Sufficient German language skills of the patient.

排除标准

  • Age < 18 years
  • The patient is under guardianship, legally incapacitated or has limited legal capacity
  • Only partial weight-bearing permitted

结局指标

主要结局

Hospital length of stay (days)

时间窗: From day of surgery until discharge, up to 4 days post-surgery

The total number of days a participant remains admitted in the hospital from the day of surgery until discharge. While the expected length of stay is approximately 4 days, some participants may stay longer depending on clinical needs.

Hip Disability and Osteoarthritis Outcome Score (HOOS)

时间窗: From baseline (pre-surgery) to 3 months post-surgery

The Hip Disability and Osteoarthritis Outcome Score (HOOS) is a validated, patient-reported instrument for assessing hip-related pain, function, and quality of life. Scores range from 0 to 100, with higher scores indicating better outcomes (less pain, better function, improved quality of life).

次要结局

  • Timed Up and Go (TUG) Test(From baseline (pre-surgery) to 3 months post-surgery)
  • EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels)(From baseline (pre-surgery) to 3 months post-surgery)
  • Range of Motion (ROM) - Neutral Zero Method (degrees)(From baseline (pre-surgery) to 3 months post-surgery)
  • Exercise Self-Efficacy Scale (ESES)(From baseline (pre-surgery) to 3 months post-surgery)
  • Pain Catastrophizing Scale (PCS)(From baseline (pre-surgery) to 3 months post-surgery)
  • Tampa Scale for Kinesiophobia (TSK)(From baseline (pre-surgery) to 3 months post-surgery)
  • Muscle Strength (Nm/kg body weight)(From baseline (pre-surgery) to 3 months post-surgery)
  • Physical Activity Enjoyment Scale (PACES)(From baseline (pre-surgery) to 3 months post-surgery)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

BarbaraVogel

Dr. rer. biol. hum.

Technical University of Munich

研究点 (1)

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