Outcomes in patients with osteoarthritis treated with minimally invasive surgery vs a conventional posterior approach in total hip arthroplasty (hip replacement)
| ISRCTN | ISRCTN63687167 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63687167 |
| Secondary identifying numbers | 10-2017 |
- Submission date
- 10/05/2020
- Registration date
- 13/05/2020
- Last edited
- 18/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Weyneshoflei 23
Bonheiden
2820
Belgium
 ORCID ID |
0000-0001-6106-2801 |
|---|---|
| Phone | +32 477829556 |
| wouter.schroven@student.kuleuven.be |
Scientific
Weyneshoflei 23
Bonheiden
2820
Belgium
| ORCID ID |
0000-0001-6106-2801 |
|---|---|
| Phone | +32 477829556 |
| wouter.schroven@student.kuleuven.be |
Study information
| Study design | Prospective single-centered double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Functional and radiographic outcomes after Superpath minimally invasive approach vs conventional posterior approach in total hip arthroplasty: a randomized controlled trial |
| Study objectives | The clinical outcome of the superpath technique is equally good as the clinical outcome of the posterolateral approach |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2017 |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Symptomatic primary osteoarthritis severe enough to warrant total hip arthroplasty |
| Key exclusion criteria | 1. Femoral neck fracture 2. Acetabulum fracture |
| Date of first enrolment | 15/10/2017 |
| Date of final enrolment | 01/02/2019 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Bornem
2880
Belgium
Sponsor information
Hospital/treatment centre
Kasteelstraat 23
Bornem
2880
Belgium
| Phone | +32 (0)3 890 16 64 |
|---|---|
| info@azr.be | |
| Website | https://www.azrivierenland.be |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/05/2020 | No | No |
Additional files
- ISRCTN63687167_PROTOCOL.pdf
- uploaded 18/05/2020
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
