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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 21 May 2019
Main ID:  DRKS00009834
Date of registration: 30/12/2015
Prospective Registration: No
Primary sponsor: Universitätsklinikum Ulm, Orthopädie
Public 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
Scientific 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
Date of first enrolment: 15/03/2015
Target sample size: 216
Recruitment status: Complete: follow-up complete
URL:  http://www.drks.de/DRKS00009834
Study type:  observational
Study design:  Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Other;  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name: Karl Philipp    Kutzner
Address:  Beethovenstr. 20 65189 Wiesbaden Germany
Telephone: 0611-1773636
Email: kkutzner@joho.de
Affiliation:  Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital Wiesbaden
Name: Karl Philipp    Kutzner
Address:  Beethovenstr. 20 65189 Wiesbaden Germany
Telephone: 0611-1773636
Email: kkutzner@joho.de
Affiliation:  Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital Wiesbaden
Key inclusion & exclusion criteria
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.
Exclusion criteria: Missing consent

Age minimum: 18 Years
Age maximum: 99 Years
Gender: Both, male and female
Health Condition(s) or Problem(s) studied
M16.1 - Other primary coxarthrosis
M16.7 - Other secondary coxarthrosis
Intervention(s)
Intervention 1: Retrospective analysis of axial subsidence of 216 implanted short-stem THA (optimys, Mathys Ltd. Bettlach) using EBRA-FCA Software on postoperatve radiographs.
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
323/13
Source(s) of Monetary Support
Mathys Ltd., Bettlach
Secondary Sponsor(s)
Ethics review
Status: approved
Approval date:
Contact:
(leading) Ethics Committee-No. (Ethik-Kommission der Universität Ulm)
Results
Results available:
Date Posted:
Date Completed: 03/11/2015
URL:
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