The exploration of the differences between two surgical approaches in total hip arthroplasty, direct anterior minimal invasive surgery and Hardinge’s approach, in obese and non-obese hip osteoarthritic patients
| ISRCTN | ISRCTN15066737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15066737 |
- Submission date
- 07/08/2019
- Registration date
- 06/09/2019
- Last edited
- 13/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
In recent years, there has been growing interest in the minimally invasive surgical techniques that are used for the performance of total hip arthroplasty (THA). Over the last decade, direct anterior minimally invasive surgery (DAMIS) has generated scientific interest because of its soft-tissue-preserving nature (intramuscular and internerve technique), combined with the relatively low risk of dislocation. On the other hand, it is well documented that the most common cause of THA is hip osteoarthritis (OA). The main risk factors for developing hip OA are advanced age, a family history of OA, previous hip injury, hip dysplasia and obesity. Specifically, a strong positive correlation has been found between obesity and hip OA (odds ratio ~2). In the literature, several studies indicate that obesity is associated with a higher complication rate after THA and with poorer clinical functional outcomes. Other studies have shown that obese patients do not differ from the non-obese in terms of postoperative outcomes. The data are controversial and further studies need to be performed in obese patients, especially comparative evaluations that compare minimally invasive techniques such as DAMIS with classical surgical interventions such as the Hardinge approach (HA). The HA was chosen because, compared to other classical surgical approaches used in obese patients, it offers good access to the hip joint and achieves a lower rate of dislocation by preserving the joint’s posterior stabilizer muscles. The aim of this study is to compare DAMIS and ΗΑ in hip OA patients undergoing primary THA, with regard to pain levels, functional status and quality of life. In addition, it will investigate whether these parameters differ between obese and non-obese patients.
Who can participate?
Patients aged over 50 with hip OA who will undergo primary total hip arthroplasty in the 4th and 2nd Orthopaedic Departments of the “KAT” General Hospital of Attica, Athens, Greece.
What does the study involve?
Comparison of the postoperative outcomes of obese and non-obese hip OA patients who have undergone primary THA through DAMIS or HA. Participants are selected from patients who have chosen to be operated by one of the two chief orthopedic surgeons/co-researchers of the present study. One of the orthopedic surgeons performs primary THA using DAMIS, whilst the other prefers the HA. Participants are divided into groups according to both the surgical approach used and their body mass index (BMI: <30 kg/m2 or ≥30 kg/m2). Specifically, the participants are divided into four groups:
Patients who undergo THA with the DAMIS technique:
Group 1: THA-DAMIS /non-obese patients (20 kg/m2 ≤ BMI < 30 kg/m2)
Group 2: THA-DAMIS/obese patients (BMI ≥ 30 kg/m2
Patients who undergo THA with the HA:
Group 3: THA-HA/non-obese patients (20 kg/m2 ≤ BMI < 30 kg/m2)
Group 4: THA-HA/obese patients (BMI ≥ 30 kg/m2)
What are the possible benefits and risks of participating?
Participants will receive a primary total hip arthroplasty as a treatment of choice for their symptomatic hip OA, regardless of the surgical technique to be performed. Information obtained from this study may benefit obese and non-obese hip OA patients undergoing THA in the future. Participation in this study entails no risk of increasing the rate of possible postoperative complications.
Where is the study run from?
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM), Physiotherapy Department, School of Health and Caring Sciences, University of West Attica, Athens, Greece and the 4th and 2nd Orthopaedic Departments of the “KAT” General Hospital of Attica, Greece.
When is the study starting and how long is it expected to run for?
January 2018 to March 2020
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Dr Sophia Stasi
soniastasi1@gmail.com
Contact information
Scientific
30 Ouranias Street
Irakleio- Attica
12243
Greece
| Phone | +30 (0)6937052737 |
|---|---|
| soniastasi1@gmail.com |
Study information
| Study design | Prospective four-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Total hip arthroplasty: direct anterior minimal invasive surgery vs Hardinge approach in obese and non-obese hip osteoarthritic patients |
| Study objectives | Direct anterior minimal invasive surgery may contribute to a faster and superior functional recovery and a better quality of life compared with the classical Hardinge approach in obese and non-obese hip osteoarthritic patients who undergo total hip arthroplasty. |
| Ethics approval(s) | Approved 21/02/2019, Ethics Committee of General Hospital of Attica “KAT” (2 Nikis street, 14561, Kifisia, Athens, Greece, Tel: +30 (0)2132086570; Email: agensec@kat-hosp.gr), ref: ΔΣ234/12-03-2019 |
| Health condition(s) or problem(s) studied | Hip osteoarthritis |
| Intervention | Total hip arthroplasty (THA) through direct anterior minimal invasive surgery (DAMIS) or Hardinge approach (HA) Comparison of the postoperative outcomes of obese and non-obese hip OA patients who have undergone primary THA through DAMIS or HA. Participants will be selected from patients who have chosen to be operated by one of the two chief orthopedic surgeons/co-researchers of the present trial. One of the orthopedic surgeons performs primary THA using DAMIS, whilst the other prefers the HA. Participants will be divided into groups according to both the surgical approach used and their body mass index (BMI: <30 kg/m2 or ≥30 kg/m2). Specifically, the participants will be divided into four groups: Patients who will undergo THA with the DAMIS technique: Group 1: THA-DAMIS/non-obese patients (20 kg/m2 ≤ BMI < 30 kg/m2) Group 2: THA-DAMIS/obese patients (BMI ≥ 30 kg/m2) Patients who will undergo THA with the HA: Group 3: THA-HA/non-obese patients (20 kg/m2 ≤ BMI < 30 kg/m2) Group 4: THA-HA/obese patients (BMI ≥ 30 kg/m2) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured preoperatively (baseline), at the end of the 4th and 8th postoperative week: 1. Pain levels evaluated using the Face Pain Scale-Revised (FPS-R) 2. Functionality measured with the Greek version of the Modified Harris Hip Score (MHHS-Gr) and the Timed Up and Go (TUG) test 3. Quality of life evaluated using the Greek version of the International Hip Outcome Tool-12 items (i-HOT12-Gr) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 11/01/2018 |
| Completion date | 19/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Total target number: 120 participants (Each of the four study groups will include 30 participants) |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Age >50 years 2. Symptomatic and radiographically confirmed hip OA 3. All participants must be ambulatory before surgery 4. Willing to be assigned to the study |
| Key exclusion criteria | 1. Dementia, chronic respiratory disease, chronic renal failure, heart failure, neurological disorder, undergoing chemotherapy, and previous osteotomy or arthroscopy to the involved hip 2. In addition, after enrolment, patients will be excluded if they present postoperative complications that might prevent them from receiving the standardized postoperative physiotherapy intervention |
| Date of first enrolment | 19/03/2018 |
| Date of final enrolment | 19/01/2020 |
Locations
Countries of recruitment
- Greece
Study participating centre
Physiotherapy Department
School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
Sponsor information
University/education
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
Physiotherapy Department
School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
| Phone | +30 (0)210 5385228 |
|---|---|
| lanecasm@uniwa.gr | |
| Website | https://lanecasm.uniwa.gr/ |
"ROR" |
https://ror.org/00r2r5k05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, is estimated to take place in March 2021. |
| IPD sharing plan | Individual participant data collected during the trial will be available after de-identification (text, tables, figures, and appendices), beginning 9 months and ending 36 months following article publication. Access will be granted to researchers who provide a methodologically sound proposal, in order for them to achieve aims in the approved proposal. Proposals should be directed to Dr Sophia Stasi (soniastasi1@gmail.com). To gain access, data requestors will need to sign a data access agreement. After 36 months the data will not be applicable. During recruitment, patients are informed of the purposes of our study. Upon acceptance, and prior to baseline measurements, participants give their written informed consent (document in Greek). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 06/09/2019 | No | No | ||
| Interim results article | Results for direct anterior approach–minimally invasive surgery in obese and non-obese patients | 06/07/2020 | 03/09/2021 | Yes | No |
| Results article | 18/11/2021 | 13/12/2021 | Yes | No |
Additional files
- ISRCTN15066737_PROTOCOL.pdf
- Uploaded 06/09/2019
Editorial Notes
13/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
03/09/2021: Publication reference added.
08/10/2019: Internal review.
06/10/2019: The protocol (not peer reviewed) been uploaded as an additional file (ISRCTN15066737_PROTOCOL).
19/08/2019: Trial's existence confirmed by ethics committee.
