Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare the direct anterior approach and the direct lateral approach in primary total hip arthroplasty, regarding the postoperative function and pain, complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical outcomes.

Detailed Description
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This is a prospective randomised controlled clinical trial and follow-up study comparing primary total hip arthroplasty performed either through a direct anterior approach or a lateral approach. At our hospital(i.e. Emergency County Hospital Cluj-Napoca), the lateral transgluteal approach was standard for more than 40 years. Starting 2008,the minimally invasive anterior approach was gradually implemented with the aim to facilitate early rehabilitation and improve functional results. Reduced blood loss, earlier functional recovery, low dislocation rates and shorter stays in hospital have been attributed to the muscle-sparing properties of the anterior approach.

Official Title
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Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty

Conditions
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Coxarthrosis

Intervention / Treatment
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* Procedure: direct anterior approach
* Procedure: direct lateral approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis of coxarthrosis Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. Exclusion Criteria: Previous surgery on affected hip The patient has inflammatory arthritis. The patient has any type of infection. The subject has a known metal allergy. Patients with co-existent ipsilateral knee disease or back problems Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition. Patients requiring bilateral hip replacement. Patient with active major psychiatric illness Patients whose body mass index (BMI; kg/m2) >35. Patients with active or suspected infection or sepsis. Patients with renal failure and/or renal insufficiency.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct anterior approach<br>Primary total hip arthroplasty using a direct anterior approach | Procedure: direct anterior approach<br>* The procedure begins by positioning the patient supine on a normal table . Both feet are draped separately to assist with dislocating and proximal femural shaft exposure.The surgical incision begins 2-4 cm lateral to the anterior superior iliac spine of the pelvis . It is then carried distally and laterally for about 8-12 cm. After protecting the lateral femoral cutaneous nerve, the fascia overlying the tensor fascia latae (TFL) is incised, and a plane is then developed between the TFL and sartorius. After coagulating the ascending branch of the lateral femoral circumflex artery, a capsulectomy is performed. Placement of the final acetabular component is facilitated by the use of an offset inserter handle. Femoral preparation begins by placing the operative limb in a position of extension, adduction and external rotation to improve the accessibility of the proximal femur. Once the final implants are in situ, the hip is reduced and assessed.<br>* Other names: modified Smith-Peterson approach;|
| Active Comparator: Direct lateral approach<br>Primary total hip arthroplasty using a direct lateral approach | Procedure: direct lateral approach<br>* The procedure begins by positioning the patient in the supine decubitus position. A longitudinal incision is made extending 3-5 cm proximal and about 5-8 cm distal to the tip of the greater trochanter . The fascia is split at the interval between the TFL and gluteus. The tendon and muscle fibres of the gluteus medius are then visualized and split . The gluteus minimus and joint capsule are split. The surgeon then dislocates the femoral head, and performs a femoral neck osteotomy. The acetabulum is prepared .Soft tissue landmarks and reamer positioning relative to the floor are used to verify acetabular version and inclination. When preparing the proximal femur, the hip is adducted and externally rotated, with the knee flexed. The femural stem is then press-fitted. Once the final implants are in situ and the hip is reduced, the stability of the construct is assessed.<br>* Other names: Hardinge approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle damage assay using Myoglobin biomarker | Before surgery, Myoglobin(ng/mL) baseline value is acquired in the morning, prior to any physical activity. Myoglobin value postoperatively is acquired at the 6 hour mark, when it reaches peak level. The change from baseline of the biomarker is calculated considering patient haemodilution. | Day of surgery | 
| Muscle damage assay using Troponin T biomarker | Before surgery, Troponin T(pg/mL) baseline value is acquired in the morning ,prior to any physical activity.Troponin T(TnT) value postoperatively is acquired at the 6 hour mark, when it reaches peak level. The change from baseline of the biomarker is calculated considering patient haemodilution. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome using Harris Hip Score | The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate pain, function, range of motion and absence of deformity, with a range of possible outcomes from 0 to 100(<70 Poor ;70 - 79 Fair; 80-89 Good; 90 -100 Excellent). The objective is to assess the dynamics of patient clinical recovery comparing functional outcome using HHS at predetermined follow-up visits and pre-op. | preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Functional outcome using the Oxford Hip Score Survey | The Oxford hip score (OHS) is a joint specific outcome measure tool designed to assess disability in patients undergoing total hip replacement (THR).The OHS is a patient-centred questionnaire that is designed to assess functional ability, and pain from the patient's perspective. It is a short, twelve-item questionnaire. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability The objective is to assess the dynamics of patient clinical recovery comparing the OHS at predetermined follow-up visits and pre-op. | preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Functional outcome using the 36-Item Short Form Health Survey (SF-36) | The SF-36 Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.The eight sections are: vitality,physical, functioning,bodily pain,general health perceptions,physical role functioning,emotional role functioning, social role functioning and mental health.The objective is to assess the dynamics of patient clinical recovery comparing the SF-36 survey at predetermined follow-up visits and pre-op. | preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Functional outcome using the 20-meters-timed-walk(66 feet) test | Performance-based measures such as the 20 meters timed walk (20MTW) Test quantify performance with tasks mimicking activities of daily living, as opposed to relying on individuals perception of performance.Hence, they may provide a more objective measure of functional capacity. The test consists in timing the patient while walking a distance of 20 meters(66feet). | at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Functional outcome using the Stair Climbing Test (SCT) | Performance-based measures such as the Stair Climbing Test (SCT) quantify performance with tasks mimicking activities of daily living, as opposed to relying on individuals perception of performance.Hence, they may provide a more objective measure of functional capacity. The test consists in timing the patient while climbing 10 steps. | at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Post Operative Pain Medication Usage | Postoperative, the amount of analgetics used by each patient is quantified (converted to opioid equivalent doses) | first 7 postoperative days - on a daily basis and then weekly for a 3 months period | 
| Pain assessment using the Visual Numeric Scale | The pain felt by the patient is measured using the Visual Numeric Scale(VNS) consisting of a scale from 0-10 (0 = no pain; 10 = worst imaginable pain). | first 7 postoperative days - on a daily basis and then weekly for a 3 months period | 
| Muscle damage - Creatine kinase (CK) | Creatine kinase (CK) - also known as creatine phosphokinase (CPK) or phospho-creatine kinase - is an enzyme expressed by various damaged tissues. Baseline value is acquired before surgery.CK-total is measured daily, the first post-op week,in the morning, to avoid physiological circadian variations. | Day of operation and next 7 consecutive days | 
| Muscle damage - Lactate dehydrogenase (LDH or LD) | Lactate dehydrogenase (LDH or LD) is an enzyme found in nearly all living cells.LDH is expressed extensively in body tissues, such as blood cells and heart muscle. Because it is released during tissue damage, it is a marker of common injuries and disease such as surgical muscle damage. Baseline value is acquired before surgery. LDH is measured daily, the first post-op week,in the morning, to avoid physiological circadian variations. | Day of operation and next 7 consecutive days | 
| Muscle damage assay using Aspartate aminotransferase (AST) | Aspartate aminotransferase (AST) is found in the liver, heart, skeletal muscle, kidneys, brain, and red blood cells. Serum AST level can be measured clinically as biomarker for muscle health. Baseline value is acquired before surgery. AST is measured daily, the first post-op week,in the morning, to avoid physiological circadian variations. | Day of operation and next 7 consecutive days | 
| radiological assessment of cup positioning in the replaced hip | Using standard X-ray of the hip - Placement of the acetabular component (inclination and version) is assessed on a Anterior-Posterior view (AP) and a Rolled Lateral view. The outcome measured is correct component placement, within the accepted range. | first day postoperative | 
| radiological assessment of stem positioning in the replaced hip | Using standard X-ray of the hip , placement of the stem is assessed on a Anterior-Posterior view (AP) and a Rolled Lateral view. The outcome measured is correct component placement, within the accepted range. | first day postoperative | 
| radiological assessment of cup and stem osteointegration in the replaced hip | The outcome measured is correct component osteointegration of the acetabular component and femoral stem using standard X-ray of the replaced hip. | 12 months postoperative | 
| Length of Hospital Stay | The length of stay will be determined for each patient,to evaluate and compare the percentage of patients who are able to be discharged in less than 5 days after undergoing total hip arthroplasty through either a direct anterior or lateral approach, utilizing the identical post operative protocol for physical recovery. | 10 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coxarthrosis, Hip arthroplasty, Direct Anterior Approach, Direct Lateral Approach