Condition category
Surgery
Date applied
19/11/2019
Date assigned
14/01/2020
Last edited
14/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.bgu-tuebingen.de/

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

.

Publication citations

Additional files

Editorial Notes

05/12/2019: Trial's existence confirmed by local ethics committee at the Faculty of Medicine at the Eberhard Karls University and the Medical Center, Tübingen.