Total Hip Replacement SurgeryPTACONFNCT06659198
Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty.
A study testing total hip replacement in people with Total Hip Replacement Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The aim of the present study is to compare the early post-operative outcomes of minimally invasive posterolateral approach (Mis-PLA) Vs. direct anterior approach (DAA) in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement Surgery
- What is being tested?
- total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2022to 30 May 2024
- 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
- clinical and instrumented diagnosis of unilateral primary or secondary end-stage hip osteoarthritis candidate to total hip arthroplasty
- patients with body mass index<30 kg/m2,
- absence of liver disease, coagulative pathology
Who cannot join
- patients with history of bleeding or thrombotic disorder,
- patients with history of liver or renal disease
- patients with anticoagulant or antiplatelet therapy
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty: a Prospective Comparative Randomized Study on Blood and Pain Management.
The aim of the present study is to compare the early post-operative outcomes of minimally invasive posterolateral approach (Mis-PLA) Vs. direct anterior approach (DAA) in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.
Fifty patients treated with THA from 2022 to 2023 are randomly assigned to either receive Mis-PLA or DAA THA. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Intraoperative and postoperative blood loss and blood transfusion rate are recorded, as well as operation time and length of stay (LOS).
Read the detailed description
Total hip arthroplasty (THA) is considered a reliable surgical strategy for the treatment of end-stage hip osteoarthritis, although it is associated with postoperative complications, such as perioperative pain and blood loss sometimes leading to blood transfusions. Recently, the concept of enhanced recovery surgery in minimally invasive joint replacement surgery is gaining popularity, as opposed to traditional approaches, which possess disadvantages such as a higher risk of dislocation, longer hospital stays and rehabilitation periods, and increased soft tissue injuries.
The minimally invasive posterolateral approach (Mis-PLA) with preserved piriformis muscle was found to minimize the amount of time needed for functional recovery, preserve prosthesis stability, reduce postoperative pain, and cause less injury and perioperative blood loss when compared to the standard procedure. It has a number of benefits, such as a very simple procedure, a clearly visible surgical field, less damage to soft tissues, and better abductor muscle preservation.
Similarly, the direct anterior approach (DAA) offers several advantages like a lower risk of dislocation, quick recovery, and less intraoperative muscle injury, although according to some studies, it possesses a longer learning curve and it is associated with prolonged operation times and significant perioperative bleeding.
This study compares the early post-operative outcomes of Mis-PLA Vs. DAA in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.
Fifty patients suffering from hip osteoarthritis treated with THA from 2022 to 2023 constitute the study sample size. Patients are subdivided into two groups and randomly assigned to either receive Mis-PLA or DAA THA.
Patients should be included if they comply with the following criteria: unilateral primary or secondary end-stage hip osteoarthritis candidate to THA, body mass index<30 kg/m2, American Society of Anesthesiologists (ASA) grade <3, absence of liver disease, coagulative pathology. Exclusion criteria are as follows: ASA grade ≥ 3, history of bleeding or thrombotic disorder, history of liver or renal disease, anticoagulant or antiplatelet therapy, refusal to participate in the study.
Patients eligible for randomization are randomly assigned to either group with a random number table randomization. Patients are followed-up up to 45 days after surgery to evaluate the occurrence of perioperative complications. This study was approved by the ethics committee of IRCCS San Raffaele Hospital, Milan, Italy, on 18/7/19 (approval number 2016005).
Patient demographics and anthropometric characteristics (age, sex, operated side, BMI) are recorded. The length of stay is calculated from admission until discharge. Peripheral blood samples are collected preoperatively and on postoperative days 1 and 3. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Total blood loss and blood transfusion rate are also recorded, as well as operation time. Blood transfusion is administered at a haemoglobin threshold of 8 g/dl in patients without comorbidities, and a threshold of 10 g/dl in patients with pre-existing cardiac pathology, according to international guidelines.
Surgical procedure of the Mis-PLA:
Following spinal anesthesia, patients are placed in lateral decubitus on the unaffected side. A short longitudinal oblique incision over the posterior aspect of the greater trochanter is performed. The sciatic nerve and gluteus medius are then shielded, the subcutaneous tissue and the underlying fascia of the tensor fasciae lata are severed, and a retractor is applied to lift the piriformis muscle upwards. After detachment of obturator internus, gemelli and quadratus, joint capsulotomy is performed. The hip is dislocated and osteotomy of the neck performed in the usual fashion. The acetabular margin is cleaned to expose the bony landmarks. Uncemented prostheses are then placed in the acetabular cup and into the femural shaft.
Surgical procedure of the DAA:
Patients are positioned supine on the table, after spinal anaesthesia is induced. A longitudinal slightly oblique incision is made on the anterior-lateral aspect of the thigh, starting 2 cm distal and lateral to the ASIS. After subcutaneous fat and fascia dissection, the interval between the tensor muscle and the rectus femoris is identified. Lateral femoral circumflex vessels are ligated and anterior hip capsule incised. After neck osteotomy and femoral head extraction, reaming, and cup placement is performed, followed by femoral preparation and stem insertion. The fascia over the tensor is stitched with sutures. Skin closure is performed and a sterile dressing is applied through a drainage previously positioned.
Peri-operative and rehabilitation protocol:
Both groups receive the same perioperative management. Antibiotics (2g of cefazolin sodium) administered intravenously before surgery. The patients are given a pre-operative dose of 15 mg/ kg tranexamic before surgery, and 15 mg/kg of the medication into the joint cavity after skin closure. Following surgery, a cold pack is placed over the surgical incision and compressive socks used. To prevent venous thromboembolism, low molecular weight heparin (LMWH) is administered subcutaneously 8 h after surgery, and prolonged up to 30 days after operation.
Postoperative oral celecoxib or other non-steroidal anti-inflammatory edication as needed are part of the postoperative pain regimen.
Patients are instructed to start early isometric quadriceps exercises and ankle pump exercises, walking with partial weight bearing with the use of crutches from the first day after surgery.
Statistical analysis Data are analyzed using Graphpad Prism v8.0 (Prism Software, La Jolla, CA, USA). Data distribution analysis is performed using the Shapiro-Wilk test. The t-test is used to analyze normally distributed data from the two groups; non parametric Mann-Withney test is used in case of non-normal distribution of data. Categorical variable are expressed as absolute and relative frequency and have been compared using Fisher's exact test. Differences are deemed statistically significant with p value < 0.05.
- Conditions
- Total Hip Replacement Surgery
- Being tested
- total hip replacement
- Keywords
- total hip replacement, minimally invasive posterolateral approach, direct anterior approach, blood management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip replacementProcedure or surgery
minimally-invasive hip replacement
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive posterior approach | Experimental | minimally invasive posterior approach total hip replacement Receives: Procedure: total hip replacement |
| direct anterior approach | Experimental | direct anterior approach total hip replacement Receives: Procedure: total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants requiring blood tranfusions
Number (percentage) of participants requiring blood tranfusions
Measured: preop to 3 days postop
Secondary outcomes (1)
Visual analog scale (VAS) score for each patient
Visual analog scale (VAS) rates pain severity froma a scale of 0 (no Pain) to 10 (worst pain possible)
Measured: preop to 3 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start28 Apr 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico San Siro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659198
- Sponsor's protocol ID
- PTACONF
- Acronym
- PTACONF
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty: a Prospective Comparative Randomized Study on Blood and Pain Management.
- ClinicalTrials.gov ID
- NCT06659198
- Acronym / sponsor ID
- PTACONF / PTACONF
- Conditions
- Total Hip Replacement Surgery
- Keywords
- total hip replacement, minimally invasive posterolateral approach, direct anterior approach, blood management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Istituto Clinico San Siro
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 26 Oct 2024 (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.
The aim of the present study is to compare the early post-operative outcomes of minimally invasive posterolateral approach (Mis-PLA) Vs. direct anterior approach (DAA) in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.
Fifty patients treated with THA from 2022 to 2023 are randomly assigned to either receive Mis-PLA or DAA THA. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Intraoperative and postoperative blood loss and blood transfusion rate are recorded, as well as operation time and length of stay (LOS).
Detailed description
Total hip arthroplasty (THA) is considered a reliable surgical strategy for the treatment of end-stage hip osteoarthritis, although it is associated with postoperative complications, such as perioperative pain and blood loss sometimes leading to blood transfusions. Recently, the concept of enhanced recovery surgery in minimally invasive joint replacement surgery is gaining popularity, as opposed to traditional approaches, which possess disadvantages such as a higher risk of dislocation, longer hospital stays and rehabilitation periods, and increased soft tissue injuries.
The minimally invasive posterolateral approach (Mis-PLA) with preserved piriformis muscle was found to minimize the amount of time needed for functional recovery, preserve prosthesis stability, reduce postoperative pain, and cause less injury and perioperative blood loss when compared to the standard procedure. It has a number of benefits, such as a very simple procedure, a clearly visible surgical field, less damage to soft tissues, and better abductor muscle preservation.
Similarly, the direct anterior approach (DAA) offers several advantages like a lower risk of dislocation, quick recovery, and less intraoperative muscle injury, although according to some studies, it possesses a longer learning curve and it is associated with prolonged operation times and significant perioperative bleeding.
This study compares the early post-operative outcomes of Mis-PLA Vs. DAA in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.
Fifty patients suffering from hip osteoarthritis treated with THA from 2022 to 2023 constitute the study sample size. Patients are subdivided into two groups and randomly assigned to either receive Mis-PLA or DAA THA.
Patients should be included if they comply with the following criteria: unilateral primary or secondary end-stage hip osteoarthritis candidate to THA, body mass index<30 kg/m2, American Society of Anesthesiologists (ASA) grade <3, absence of liver disease, coagulative pathology. Exclusion criteria are as follows: ASA grade ≥ 3, history of bleeding or thrombotic disorder, history of liver or renal disease, anticoagulant or antiplatelet therapy, refusal to participate in the study.
Patients eligible for randomization are randomly assigned to either group with a random number table randomization. Patients are followed-up up to 45 days after surgery to evaluate the occurrence of perioperative complications. This study was approved by the ethics committee of IRCCS San Raffaele Hospital, Milan, Italy, on 18/7/19 (approval number 2016005).
Patient demographics and anthropometric characteristics (age, sex, operated side, BMI) are recorded. The length of stay is calculated from admission until discharge. Peripheral blood samples are collected preoperatively and on postoperative days 1 and 3. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Total blood loss and blood transfusion rate are also recorded, as well as operation time. Blood transfusion is administered at a haemoglobin threshold of 8 g/dl in patients without comorbidities, and a threshold of 10 g/dl in patients with pre-existing cardiac pathology, according to international guidelines.
Surgical procedure of the Mis-PLA:
Following spinal anesthesia, patients are placed in lateral decubitus on the unaffected side. A short longitudinal oblique incision over the posterior aspect of the greater trochanter is performed. The sciatic nerve and gluteus medius are then shielded, the subcutaneous tissue and the underlying fascia of the tensor fasciae lata are severed, and a retractor is applied to lift the piriformis muscle upwards. After detachment of obturator internus, gemelli and quadratus, joint capsulotomy is performed. The hip is dislocated and osteotomy of the neck performed in the usual fashion. The acetabular margin is cleaned to expose the bony landmarks. Uncemented prostheses are then placed in the acetabular cup and into the femural shaft.
Surgical procedure of the DAA:
Patients are positioned supine on the table, after spinal anaesthesia is induced. A longitudinal slightly oblique incision is made on the anterior-lateral aspect of the thigh, starting 2 cm distal and lateral to the ASIS. After subcutaneous fat and fascia dissection, the interval between the tensor muscle and the rectus femoris is identified. Lateral femoral circumflex vessels are ligated and anterior hip capsule incised. After neck osteotomy and femoral head extraction, reaming, and cup placement is performed, followed by femoral preparation and stem insertion. The fascia over the tensor is stitched with sutures. Skin closure is performed and a sterile dressing is applied through a drainage previously positioned.
Peri-operative and rehabilitation protocol:
Both groups receive the same perioperative management. Antibiotics (2g of cefazolin sodium) administered intravenously before surgery. The patients are given a pre-operative dose of 15 mg/ kg tranexamic before surgery, and 15 mg/kg of the medication into the joint cavity after skin closure. Following surgery, a cold pack is placed over the surgical incision and compressive socks used. To prevent venous thromboembolism, low molecular weight heparin (LMWH) is administered subcutaneously 8 h after surgery, and prolonged up to 30 days after operation.
Postoperative oral celecoxib or other non-steroidal anti-inflammatory edication as needed are part of the postoperative pain regimen.
Patients are instructed to start early isometric quadriceps exercises and ankle pump exercises, walking with partial weight bearing with the use of crutches from the first day after surgery.
Statistical analysis Data are analyzed using Graphpad Prism v8.0 (Prism Software, La Jolla, CA, USA). Data distribution analysis is performed using the Shapiro-Wilk test. The t-test is used to analyze normally distributed data from the two groups; non parametric Mann-Withney test is used in case of non-normal distribution of data. Categorical variable are expressed as absolute and relative frequency and have been compared using Fisher's exact test. Differences are deemed statistically significant with p value < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive posterior approach | Experimental | Procedure: total hip replacementminimally invasive posterior approach total hip replacement |
| direct anterior approach | Experimental | Procedure: total hip replacementdirect anterior approach total hip replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical and instrumented diagnosis of unilateral primary or secondary end-stage hip osteoarthritis candidate to total hip arthroplasty
- patients with body mass index<30 kg/m2,
- absence of liver disease, coagulative pathology
Key exclusion criteria (4 listed)
- patients with history of bleeding or thrombotic disorder,
- patients with history of liver or renal disease
- patients with anticoagulant or antiplatelet therapy
- refusal to participate in the study
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 |
|---|---|---|
| total hip replacementminimally-invasive hip replacement | Procedure or surgery | direct anterior approach, minimally invasive posterior approach |
Primary outcome
Number of participants requiring blood tranfusions
Time frame: preop to 3 days postop
Number (percentage) of participants requiring blood tranfusions
1 secondary outcome
Visual analog scale (VAS) score for each patient
Time frame: preop to 3 days postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip replacement in people with Total Hip Replacement Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Oct 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants requiring blood tranfusions (time frame: preop to 3 days postop). 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 26 Oct 2024.