Influence of patient-related characteristics on early migration in calcar-guided short-stem total hip arthroplasty: A two-year migration analysis using EBRA-FCA
Organizational Data
- DRKS-ID:
- DRKS00009834
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-12-30
- Last update in DRKS:
- 2015-12-30
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- M16.1 - Other primary coxarthrosis
- ICD10:
- M16.7 - Other secondary coxarthrosis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Retrospective analysis of axial subsidence of 216 implanted short-stem THA (optimys, Mathys Ltd. Bettlach) using EBRA-FCA Software on postoperatve radiographs.
Endpoints
- 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.
- 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.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Unversitätsklinikum Ulm, Orthopädie Ulm
- Medical center St. Josefs Hospital Wiesbaden Wiesbaden
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-03-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-11-03
- Target Sample Size:
- 216
- Final Sample Size:
- 216
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- 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.
Exclusion Criteria
Missing consent
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Ulm, OrthopädieProf. Dr. med. Heiko ReichelOberer Eselsberg 4589081 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital WiesbadenDr. med. Karl Philipp KutznerBeethovenstr. 2065189 WiesbadenGermany
- Telephone:
- 0611-1773636
- Fax:
- 0611-1773639
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.joho.de
Contact for Public Queries
- Address:
- Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital WiesbadenDr. med. Karl Philipp KutznerBeethovenstr. 2065189 WiesbadenGermany
- Telephone:
- 0611-1773636
- Fax:
- 0611-1773639
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.joho.de
Principal Investigator
- Address:
- Klinik für Orthopädie und Unfallchirurgie, St. Josefs Hospital WiesbadenDr. med. Karl Philipp KutznerBeethovenstr. 2065189 WiesbadenGermany
- Telephone:
- 0611-1773636
- Fax:
- 0611-1773639
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.joho.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Mathys Ltd., BettlachRobert Mathys Str. 52544 BettlachSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-11-04
- Ethics committee number:
- 323/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-01-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry