Condition category
Musculoskeletal Diseases
Date applied
10/05/2020
Date assigned
13/05/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.azrivierenland.be

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

Editorial Notes

18/05/2020: Uploaded protocol (not peer reviewed) as an additional file. 13/05/2020: Trial’s existence confirmed by Ethics committee Az Rivierenland