Hip OsteoarthritisNCT04311125
Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty
A study testing Mini posterior approach Total Hip Replacement, Anterior approach total hip replacement without a traction table and Anterior approach total hip replacement with a traction table in people with Hip Osteoarthritis and Hip Arthropathy, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Minimal Invasive
- What is being tested?
- Mini posterior approach Total Hip Replacement, Anterior approach total hip replacement without a traction table and Anterior approach total hip replacement with a traction table
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that sign the Informed consent
- Patients aged 18 years and over who are going to undergo primary total hip arthroplasty
Who cannot join
- Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index >30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Orthopaedics
Athens, Attica, 14233
Vasileios Nikolaou, MD, MSc, PhD, +306932543400, vassilios.nikolaou@gmail.com
Michael Sarantis, MD
About this study
Official title: Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period
Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.
- Being tested
- Mini posterior approach Total Hip Replacement, Anterior approach total hip replacement without a traction table, Anterior approach total hip replacement with a traction table
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini posterior approach Total Hip ReplacementProcedure or surgery
Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach
Anterior approach total hip replacement without a traction tableProcedure or surgery
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table
Anterior approach total hip replacement with a traction tableProcedure or surgery
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table
| Study group | Role | What they receive |
|---|---|---|
| total hip arthroplasty via the mini posterior approach | Active comparator | total hip arthroplasty via the mini posterior approach. This approach was first described by Kocher and Langenbeck and later modified by Gibson in 1950. There is a convex incision centered on the posterior rim of the major trochanter. The incision follows the curve of the buttock and at the height of the posterior lip of the major trochanter, it is peripherally oriented along the posterior outer surface of the femur. The major gluteus is divided along the muscle fibers. Guiding sutures are inserted into the tendon mass of the hip rotor muscles just prior to their origin on the major trochanter and dissected to expose and subsequently retract the posterior hip capsule. Receives: Procedure: Mini posterior approach Total Hip Replacement |
| THR via the anterior approach without traction table | Active comparator | The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery. Receives: Procedure: Anterior approach total hip replacement without a traction table |
| THR via the anterior approach with a traction table | Active comparator | The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery. Receives: Procedure: Anterior approach total hip replacement with a traction table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue damage change
Investigate and quantify at the biochemical level with all available biomarkers the extent of tissue damage caused during a hip arthroplasty between different hip surgical approaches.
Measured: Change from 6 to 24 and then 48 hours post-surgery
Secondary outcomes (2)
Imaging
All patients will be subjected to imaging with a hip MRI
Measured: Day 30 after surgery
Clinical Tests change
All patients will be monitored postoperatively for the prescribed period and data will be recorded.
Measured: Change to clinical test from Day 2 to day 15 and then day 30 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios S. Nikolaou, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311125
- Sponsor's protocol ID
- 4
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT04311125
- Acronym / sponsor ID
- 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| total hip arthroplasty via the mini posterior approach | Active comparator | Procedure: Mini posterior approach Total Hip Replacementtotal hip arthroplasty via the mini posterior approach. This approach was first described by Kocher and Langenbeck and later modified by Gibson in 1950. There is a convex incision centered on the posterior rim of the major trochanter. The incision follows the curve of the buttock and at the height of the posterior lip of the major trochanter, it is peripherally oriented along the posterior outer surface of the femur. The major gluteus is divided along the muscle fibers. Guiding sutures are inserted into the tendon mass of the hip rotor muscles just prior to their origin on the major trochanter and dissected to expose and subsequently retract the posterior hip capsule. |
| THR via the anterior approach without traction table | Active comparator | Procedure: Anterior approach total hip replacement without a traction tableThe anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery. |
| THR via the anterior approach with a traction table | Active comparator | Procedure: Anterior approach total hip replacement with a traction tableThe anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that sign the Informed consent
- Patients aged 18 years and over who are going to undergo primary total hip arthroplasty
Key exclusion criteria (1 listed)
- Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index >30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini posterior approach Total Hip ReplacementTotal hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach | Procedure or surgery | total hip arthroplasty via the mini posterior approach |
| Anterior approach total hip replacement without a traction tableMini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table | Procedure or surgery | THR via the anterior approach without traction table |
| Anterior approach total hip replacement with a traction tableMini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table | Procedure or surgery | THR via the anterior approach with a traction table |
Primary outcome
Tissue damage change
Time frame: Change from 6 to 24 and then 48 hours post-surgery
Investigate and quantify at the biochemical level with all available biomarkers the extent of tissue damage caused during a hip arthroplasty between different hip surgical approaches.
2 secondary outcomes
Imaging
Time frame: Day 30 after surgery
Clinical Tests change
Time frame: Change to clinical test from Day 2 to day 15 and then day 30 post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini posterior approach Total Hip Replacement, Anterior approach total hip replacement without a traction table and Anterior approach total hip replacement with a traction table in people with Hip Osteoarthritis and Hip Arthropathy, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Nikolaou (+306932543400, vassilios.nikolaou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue damage change (time frame: Change from 6 to 24 and then 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.