Trial document




This trial has been registered retrospectively.
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  DRKS00014808

Trial Description

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Title

Influence of two surgical approaches on the postoperative course of recovery and the clinical outcome after total hip arthroplasty

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The prospective randomized controlled single-centre study compares the clinical outcome up to twelve months after total hip arthroplasty using a minimally invasive single-incision direct anterior (DAA) and a direct transgluteal lateral approach.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014808
  •   2018/05/31
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  •   yes
  •   Approved
  •   72/11 , Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
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Interventions/Observational Groups

  •   hip arthroplasty using a minimally invasive anterior approach
  •   hip arthroplasty using a transgluteal lateral appraoch
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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
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Patient activity as determined by the Stepwatch™ Activity Monitor preoperatively as well as 3, 6 and 12 months after surgery

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Secondary Outcome

Secondary outcome measures include the
- Harris hip score (HHS)
- extra short musculoskeletal functional assessment questionnaire (XSMFA functional and bother index, 16 items)
- a timed 25 meter foot walk (T25-FW)
- and the short-form 36 questionnaire (SF-36 mental and physical component summaries).
The measurements are taken preoperatively and 6 weeks as well as three, six and twelve monthts after surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/12/12
  •   138
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary osteoarthritis of the hip

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Exclusion Criteria

age < 40 or > 80 years,
Body-Mass-Index (BMI) > 35 kg/m²,
hip dysplasia or a congenital disorder of the hip, former osteotomies of hip, knee or pelvis; an impairment of the contralateral side or osteoarthritis of the ipsilateral knee, osteoporosis, degenerative spine disease, or a severe systemic disease (ASA-Score ≥ 4, malignant or cardiovascular disease)

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Addresses

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    • Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität Würzburg
    • Mr.  Prof. Dr. med. habil.  Ulrich  Nöth 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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    • Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität Würzburg
    • Mr.  Dr. Dr. med.   Johannes  Reichert 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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    • Orthopädische Klinik König-Ludwig-Haus
    • Mr.  Prof. Dr. med. habil.  Ulrich  Nöth 
    • Brettreichstr. 11
    • 97074  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Arthrose-Hilfe e.V.
    • Postfach 11 05 51
    • 60040  Frankfurt/Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/31
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Trial Publications, Results and other Documents

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