Trial document




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  DRKS00017096

Trial Description

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Title

Impact of early mobilisation on the day of the surgery on patients with a primary total hip replacement

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Trial Acronym

FAST_HIP_KLH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study was designed to investigate the effect of the timing the patient first gets up after total hip arthroplasty.
The patients will be randomly divided into two groups. The patients in both groups will be treated in exactly the same way according to our hospital standard except the timing of the first get up after the surgery. Patients in group 1 will be mobilized on the day of the surgery. Patients in group 2 will be mobilized on the first day after the surgery. Hereafter we will record the mobility, the pain management and possible complications on every day until the patient's discharge.
We hope that this data will help us to find out, when the patients should be first mobilized after hip arthroplasty to have the greatest benefit.

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Brief Summary in Scientific Language

In this prospective monocentric clinical study we aim to investigate the effect of the timing of the start of the mobilization after primary total hip arthroplasty.
Therefore, the included patients will be block-randomized by an independent institute into two groups. Patients in group 1 will be mobilized on the day of the surgery, approximately 4 hours after the end of surgery. Patients in group 2 will be mobilized on the first day after the surgery.
Throughout the patient's stay in hospital we will record the mobility, the pain intensity, the analgesic intake, complications and the length of stay of all included patients.
Primary outcome is the time to achieve a state of recovery that allows the patient's discharge. Secondary outcome variables are the courses of pain intensity, mobility and analgesic intake as well as possible complication.
This will allow us to find out if the mobilization on the day of surgery is beneficial for the patient.

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Organizational Data

  •   DRKS00017096
  •   2019/07/12
  •   [---]*
  •   yes
  •   Approved
  •   16/19-sc, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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Health Condition or Problem studied

  •   M16.9 -  Coxarthrosis, unspecified
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Interventions/Observational Groups

  •   Patients will be mobilized on the day of the surgery approximately 4 hours after surgery.
  •   Patients will be mobilized one day after the day of surgery.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Time interval between surgery and readiness for discharge.

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Secondary Outcome

1. pain intensity (will be recorded independently from the study by the staff nurses according to hospital standard).
2. analgesic intake (will be recorded independently from the study by the staff nurses according to hospital standard).
3. mobility (will be recorded independently from the study by the staff physiotherapists according to hospital standard).
4. complications (will be recorded independently from the study by the staff physician according to hospital standard).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/15
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Implantation of a primary total hip replacement, alt least 18 years of age, Patient information orally and in writing, written consent

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Exclusion Criteria

Primary exclusion criteria: Planned use of surgical drain or additional surgical procedures that do not allow day-of-surgery mobilization.

Secondary exclusion criteria: Occurrence of complications or unplanned use of drain or the occurence of complications that do not allow day-of-surgery mobilization.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Orthopädische Klinik König-Ludwig-Haus
    • Mr.  Prof. Dr.  Maximilian  Rudert 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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    • Orthopädische Klinik König-Ludwig-Haus
    • Mr.  Dr. med.  Axel  Jakuscheit 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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    • Orthopädische Klinik König-Ludwig-Haus
    • Mr.  Dr. med.  Axel  Jakuscheit 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Orthopädische Klinik König-Ludwig-Haus
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.