Trial document





This trial has been registered retrospectively.
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  DRKS00000668

Trial Description

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Title

fast track rehabilitation after total hip and knee replacement

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

the effect of fast track rehabilitation on recovery pattern in total hip and knee replacement

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Brief Summary in Scientific Language

This is an open, randomized, prospective clinical study, comparing the fast track treatment pathway-controlled early recovery program (Joint Care®) with standard postoperative rehabilitation after total hip and total knee replacement. The fast track rehabilitation group received a group therapy and early mobilization (same day as surgery) and 1:1 physiotherapy (2 h/day). Patient monitoring occurred over 3 months (1 pre- and 4 post-operative visits). The standard rehabilitation group received individual postoperative care according to the existing protocols and guidelines, with 1:1 physiotherapy (1 h/day). The Harris hip score (HHS) and the American Knee Society Score (AKSS) were the primary study variable as ‘area under the curve’, to detect changes in joint function and perception of pain. The secondary study variables were WOMAC score, analgesic drug consumption, length of stay, and safety. The hypothesis of inferiority in fast track surgery was withdrawn.

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Organizational Data

  •   DRKS00000668
  •   2011/01/05
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  •   yes
  •   Approved
  •   Bo/08/05, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  •   U1111-1118-8269 
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Health Condition or Problem studied

  •   M16.9 -  Coxarthrosis, unspecified
  •   M17.9 -  Gonarthrosis, unspecified
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Interventions/Observational Groups

  •   traditional care: mobilisation when patient felt fit for it physiotherapy 1hr. daily, no fixed therapeutic targets, discharge, when patient felt comfortable, minimal discharge criteria:
    Patient feels comfortable, Low to moderate pain (indicating adequate analgesic medication), no wound leakage, independence in ‘Activities of Daily Living’ (ADL) such as independent transfer, body hygiene, etc., Independent mobility (partial weight bearing, walking distance >250m).
  •   fast track care:
    The fast track pathway is characterized by early mobilization with standardized postoperative milestones. These include getting up on the day of the surgery, climbing stairs two days after surgery, improved organization involving a case manager, stating positive messages to the patient ‘yes, you can’, using competitive care by comparing the progress with fellow patients, standard intensive physiotherapy (2 h daily) with focus on ‘Activities of Daily Living’ (ADL) in a living room environment, and individual case management. Patients were aware that early discharge was scheduled for the postoperative day 6. Nevertheless, the discharge criteria had to be fulfilled; if this was not the case, discharge was postponed.
    discharge criteria:
    Patient feels comfortable, Low to moderate pain (indicating adequate analgesic medication), no wound leakage, independence in ‘Activities of Daily Living’ (ADL) such as independent transfer, body hygiene, etc., Independent mobility (partial weight bearing, walking distance >250m).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

area under curve in Harris Hip Score or American Knee Society Score within observation period of 3 Months. Patient monitoring was scheduled in 5 visits, preoperatively, 5-7 days , 15-23 days , 6 weeks and three months after surgery. Data were obtained through standardized questionnaires and reports. A study nurse was resoponsible for correct data collection

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Secondary Outcome

Analysis of WOMAC index, medication and Length of stay. WOMAC index was obtained at the same Visits as HHS and AKSS. Medication was monitored day by day. Length of stay was documented

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2005/10/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

Patients admitted for total Hip or total Knee arthroplasty and surgery indicated.

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Exclusion Criteria

missing informed consent, lack of cooperation capability, American Society of Anesthesiologists (ASA) score >3, rheumatoid arthritis, cancer co-morbidity, alcohol or drug abuse, previous major surgery on the affected joint, neurologic or psychiatric disease, pregnancy, participation in other clinical studies.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • privatärztliche Praxis
    • Mr.  Dr. med.  Adrianus  den Hertog 
    • Am Fuhrenkamp 2
    • 27798  Hude
    • Germany
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    • privatärztliche Praxis
    • Mr.  Dr. med.  Adrianus  den Hertog 
    • Am Fuhrenkamp 2
    • 27798  Hude
    • Germany
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    • privatärztliche Praxis
    • Mr.  Dr. med.  Adrianus  den Hertog 
    • Am Fuhrenkamp 2
    • 27798  Hude
    • Germany
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Sources of Monetary or Material Support

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    • Krankenhaus Stenum Fachklinik für Orthopädie
    • Heilstättenweg 1
    • 27777  Ganderkesee
    • Germany
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    • Barmer GEK Krankenkasse
    • Bleicherstr. 1
    • 26122   Oldenburg
    • Germany
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    • Biometdeutschland GmbH
    • Gustav-Krone-Str. 2
    • 14167  Berlin
    • Germany
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    • DAK
    • Ellernstr. 40
    • 30175  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/10/01
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Trial Publications, Results and other Documents

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