Trial document





This trial has been registered retrospectively.
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  DRKS00009834

Trial Description

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Title

Influence of patient-related characteristics on early migration in calcar-guided short-stem total hip arthroplasty: A two-year migration analysis using EBRA-FCA

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Implant migration of a modern total hip prosthesis was assessed using a Computer assisted technique in a two year follow-up. Full weight-bearing was allowed directly after surgery. Patients were divided into groups regarding gender, age, weight, BMI and offset version. Influence of Patient related characteristics on subsidence was assessed. Clinical Scores were analyzed.

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Brief Summary in Scientific Language

Short-stems have gained popularity in THA over the last years. Because of excellent clinical results, indications have been expended to young but also elderly and obese patients. However, long-term results are lacking. The purpose of this study was an evaluation of the influence of gender, age, weight, body mass index (BMI) and offset version of the stem on short-stem migration in correlation to the clinical outcome.
Implant migration of metaphyseal anchoring, calcar guided short-stems was assessed by “Einzel-Bild-Roentgen-Analyse” (EBRA-FCA, femoral component analysis) in a two year follow-up. Full weight-bearing was allowed directly after surgery. Patients were divided into groups regarding gender, age, weight, BMI and offset version. Influence of Patient related characteristics on axial subsidence was assessed. Harris Hip Score (HHS) and satisfaction on visual analoque scale (VAS) were analyzed.

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Organizational Data

  •   DRKS00009834
  •   2015/12/30
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  •   yes
  •   Approved
  •   323/13, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   M16.1 -  Other primary coxarthrosis
  •   M16.7 -  Other secondary coxarthrosis
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Interventions/Observational Groups

  •   Retrospective analysis of axial subsidence of 216 implanted short-stem THA (optimys, Mathys Ltd. Bettlach) using EBRA-FCA Software on postoperatve radiographs.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Axial Subsidence of Short-Stem (measured in mm by EBRA-FCA Software on postoperative radiographs) postoperatively, after 6 weeks, after 6 months, after 12 months, after 24 months.

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Secondary Outcome

Patient related influences on subsidence (statistical Analysis of clinical data in regard to axial subsidence) + Clinical Scores (Harris Hip Score (HHS) and satisfaction on visual analoque scale (VAS)) during follow-up mentioned above.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/03/15
  •   216
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

a minimum follow-up of two years; a series of at least three consecutive standardized radiographs accepted by the EBRA-FCA software and acceptance of the direct postoperative and the 24 months follow-up radiograph.

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Exclusion Criteria

Missing consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Ulm, Orthopädie
    • Mr.  Prof. Dr. med.  Heiko  Reichel 
    • Oberer Eselsberg 45
    • 89081  Ulm
    • Germany
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    • Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital Wiesbaden
    • Mr.  Dr. med.  Karl Philipp  Kutzner 
    • Beethovenstr. 20
    • 65189  Wiesbaden
    • Germany
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    • Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital Wiesbaden
    • Mr.  Dr. med.  Karl Philipp  Kutzner 
    • Beethovenstr. 20
    • 65189  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Mathys Ltd., Bettlach
    • Robert Mathys Str. 5
    • 2544  Bettlach
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/03
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Trial Publications, Results and other Documents

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