Plain English Summary
Background and study aims
A hip replacement (hip arthroplasty) is a common type of surgery where a damaged hip joint is replaced with an artificial one (known as an implant).
The purpose of this study was to compare the functional outcome, perioperative parameters and complications of minimal invasive surgery (SuperPath) to the conventional posterior technique during a follow up period of 6-12 months. These parameters are important, because of rising attention in orthopedic surgery for minimal invasive techniques, despite the ongoing uncertainty about the benefits of MIS.
Who can participate?
Adults over 18 years, with osteoarthritis severe enough to warrant total hip replacement.
What does the study involve?
This study reports the results of a prospective double-blinded randomized controlled trial of patients with primary hip osteoarthritis. The surgery was performed in a single center by one senior orthopaedic chief surgeon, who has elaborate prior experience in hip surgery. Between October 2017 and February 2019, 60 patients who suffered from radiographically confirmed hip osteoarthritis were divided into two groups and treated according to allocation. Treatment consisted of either a minimal invasive surgery approach or a conventional posterior approach. Peri-operative parameters were collected and compared. Questionnaires (harris hip score and Hip disability and osteoarthritis outcome score) to measure functional outcome were taken 6 weeks and up to 6 months postoperative.
What are the possible benefits and risks of participating?
Benefits: contributing to science
Risks: Regular risks of total hip arthroplasty (infection, blood clots, fracture,...)
Where is the study run from?
AZ Rivierenland (Belgium)
When is the study starting and how long is it expected to run for?
October 2017 to August 2019
Who is funding the study?
investigator initiated and funded
Who is the main contact?
Wouter Schroven, wouter.schroven@student.kuleuven.be
Trial website
Contact information
Type
Public
Primary contact
Mr Wouter Schroven
ORCID ID
http://orcid.org/0000-0001-6106-2801
Contact details
Weyneshoflei 23
Bonheiden
2820
Belgium
+32 477829556
wouter.schroven@student.kuleuven.be
Type
Scientific
Additional contact
Mr Wouter Schroven
ORCID ID
http://orcid.org/0000-0001-6106-2801
Contact details
Weyneshoflei 23
Bonheiden
2820
Belgium
+32 477829556
wouter.schroven@student.kuleuven.be
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
10-2017
Study information
Scientific title
Functional and radiographic outcomes after Superpath minimally invasive approach vs conventional posterior approach in total hip arthroplasty: a randomized controlled trial
Acronym
Study hypothesis
The clinical outcome of the superpath technique is equally good as the clinical outcome of the posterolateral approach
Ethics approval
Approved 20/10/2017, Ethics committee Az Rivierenland (Kasteelstraat 23, 2880, Bornem, Belgium; +32 (0)3 890 16 64; Dr.Van.Landuyt@sjk.be), ref: none provided
Study design
Prospective single-centered double-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Total hip arthroplasty
Intervention
Patients presenting with primary hip osteoarthritis and requiring arthroplasty will be randomized to one of two groups. Randomization will be done using a random number generator and sealed envelopes. Patients will not be aware of which type of approach they will receive.
Group 1 will receive the supercapsular percutaneously-assisted total hip surgery SuperPath), a minimally invasive approach.
Group 2 will be treated with a conventional posterior approach (Moore).
Prior to surgery, every patient will be broadly informed about the course of the study, the possible risks and the right to withdraw at any moment.
Harris hip score and Hip disability and osteoarthritis outcome score will be examined pre-operative, 6 weeks postoperative and up to 6 months postoperative. Perioperative parameters (Hb, operation time, length of stay, NRS-score) will also be investigated.
One day after surgery, a routine X-ray will be taken to measure prosthesis positioning. During data collection, the investigators will be blinded for the type of surgery that was administered.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Harris hip score and Hip disability and osteoarthritis outcome score at baseline, 6 weeks and up to 6 months postoperatively
Secondary outcome measures
1. Radiograpic prosthesis positioning (cup abduction angle, stem alignment) measured using X-ray one day after operation
2. Perioperative parameters (Hb, transfusion rate, length of stay, NRS score, operation time) at the time of operation
Overall trial start date
01/10/2017
Overall trial end date
01/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Symptomatic primary osteoarthritis severe enough to warrant total hip arthroplasty
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Femoral neck fracture
2. Acetabulum fracture
Recruitment start date
15/10/2017
Recruitment end date
01/02/2019
Locations
Countries of recruitment
Belgium
Trial participating centre
AZ Rivierenland
Kasteelstraat 23
Bornem
2880
Belgium
Sponsor information
Organisation
AZ Rivierenland
Sponsor details
Kasteelstraat 23
Bornem
2880
Belgium
+32 (0)3 890 16 64
info@azr.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The manuscript is intended to be published in a peer reviewed journal. The trial results, as well as an overview of the statistical analysis, will be published in the journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Wouter Schroven, Schrovenwouter@hotmail.com, all data relevant for research documented available from 11/05/2020. The data is documented in an Excel-file and available upon request. Participants were informed and consent was given to share anonymized data, framed in professional secrecy.
Intention to publish date
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN63687167_PROTOCOL.pdf uploaded 18/05/2020