Plain English Summary
Background and study aims
Periprosthetic fractures (Vancouver type B2/B3) after total hip arthroplasty (hip replacement) are an increasing and challenging problem. Only limited evidence is available for this type of fracture treated with modular stems. Therefore, this study evaluated the outcome of Vancouver type B2/B3 fractures treated with a modular hip revision stem using a subproximal/distal anchorage and compared it with the current literature.
Who can participate?
Patients with Vancouver B2 and B3 fractures recorded between 2013 and 2016 and treated with a cementless, modular, fluted, tapered revision stem (Prevision®, B. Braun Aesculap AG, Tuttlingen, Germany)
What does the study involve?
The clinical and radiographic outcomes of patients with femoral fractures around their total hip replacements are evaluated after surgical treatment. Furthermore, complications are evaluated as well. The study involves a clinical examination as well as scores and regular x-rays of the affected hip.
What are the possible benefits and risks of participating?
There are no risks in participating as the follow-up is similar to a regular follow-up in clinic with the benefit of informing the patient and treating possible complications.
Where is the study run from?
Eberhard Karls University Tübingen (Germany)
When is the study starting and how long is it expected to run for?
October 2015 to December 2018
Who is funding the study?
B. Braun, Aesculap
Who is the main contact?
Dr Florian Schmidutz
fschmidutz@bgu-tuebingen.de
Trial website
Contact information
Type
Public
Primary contact
Dr Florian Schmidutz
ORCID ID
Contact details
Schnarrenbergstr. 95
Tübingen
72076
Germany
+49 (0)7071 6063803
fschmidutz@bgu-tuebingen.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
621/2015BO2
Study information
Scientific title
Hip revision arthroplasty of periprosthetic fractures Vancouver B2 and B3 with a modular revision stem: short-term results and review of literature
Acronym
Prevision
Study hypothesis
Periprosthetic Vancouver type B2 and B3 fractures are challenging to treat and there is no consent about the stem design and technique. Furthermore, there is only limited number of studies with moderate number of cases for fractures Vancouver type B2 and B3.
The researchers therefore analyzed the outcome of Vancouver B2 and B3 fractures using a cementless, modular revision stem with a subproximal and distal fixation using a modified transfemoral approach. The aim was to show that the modular revision stem inserted via a transfemoral approach would lead to good or at least comparable results in terms to fracture healing, fixation of the stem, subsidence and functional outcome compared to stems with proximal fixation and the current literature.
Ethics approval
Approved 01/10/2015 by the local ethics committee at the Faculty of Medicine at the Eberhard Karls University and the Medical Center, Tübingen (Gartenstrasse 47, 72074 Tübingen, Germany; Tel: +49 (0)7071 29-77661; Email: ethik.kommission@med.uni-tuebingen.de), ref: 621/2015BO2
Study design
A consecutive series of periprosthetic Vancouver type B2/B3 fractures treated with a modular revision stem via a modified transfemoral approach was retrospectively (2013-2016) evaluated (observational study).
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use contact details to request a participant information sheet.
Condition
Orthopaedic surgery: Vancouver B2/3 periprosthetic fractures
Intervention
A consecutive series of periprosthetic Vancouver type B2/B3 fractures treated with a modular revision stem via a modified transfemoral approach was retrospectively (2013-2016) evaluated. The assessment included the clinical (HHS, pain, ROM) as well as the radiological outcome (subsidence, loosening, fracture healing).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Clinical and radiological outcome, measured using the Harris Hip Score and a regular clinical examination comprising palpation of the site as well as evaluation of ROM (range of motion) and standardized radiographs of the affected hip in two planes at the time of the patients' individual postoperative follow-up
Secondary outcome measures
Complications, measured by analyzing clinical and radiological outcome combined with data from the digital clinical information charts regarding subsequent surgeries as well as any kind of complication occurred for the duration of the study
Overall trial start date
01/10/2015
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All consecutive Vancouver B2 and B3 fractures that were recorded between 2013 and 2016 and treated with a cementless, modular, fluted, tapered revision stem (Prevision®, B. Braun Aesculap AG, Tuttlingen, Germany) were included and retrospectively analyzed. The patients who could be contacted were examined clinically and radiologically within the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Retrospectively analyzed case series of all available cases as defined above (18)
Total final enrolment
18
Participant exclusion criteria
1. Insufficient data or follow-up at less than 3 months
2. Patients who suffered from dementia
3. Insufficient knowledge of the study language
4. incapable of participating in the study due to severe health conditions
Recruitment start date
01/01/2016
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Germany
Trial participating centre
BG Trauma Center Tübingen,
Department of Arthroplasty
Eberhard Karls University Tübingen
Schnarrenbergstrasse 95
Tübingen
72076
Germany
Sponsor information
Organisation
BG Trauma Center Tübingen
Sponsor details
Schnarrenbergst. 95
Tübingen
72076
Germany
+49 (0)7071 6063803
fschmidutz@bgu-tuebingen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
B. Braun, Aesculap
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers plan to submit the paper to "Orthopedics".
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Florian Schmidutz (fschmidutz@bgu-tuebingen.de) and Dr Anna J. Schreiner (annajschreiner@yahoo.de). The data comprises Excel spreadsheets, consent from participants was obtained.
Intention to publish date
22/11/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
.