Back to resultsDirect Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty (DAAvsDLA)
Primary Purpose
Coxarthrosis
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
direct anterior approach
direct lateral approach
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis focused on measuring Coxarthrosis, Hip arthroplasty, Direct Anterior Approach, Direct Lateral Approach
Eligibility Criteria
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.
Sites / Locations
- Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Direct anterior approach
Direct lateral approach
Arm Description
Primary total hip arthroplasty using a direct anterior approach
Primary total hip arthroplasty using a direct lateral approach
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
Post Operative Pain Medication Usage
Postoperative, the amount of analgetics used by each patient is quantified (converted to opioid equivalent doses)
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).
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02719236
First Posted
February 12, 2016
Last Updated
February 8, 2021
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Collaborators
Emergency County Hospital Cluj-Napoca
1. Study Identification
Unique Protocol Identification Number
NCT02719236
Brief Title
Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty
Acronym
DAAvsDLA
Official Title
Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Collaborators
Emergency County Hospital Cluj-Napoca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
Coxarthrosis, Hip arthroplasty, Direct Anterior Approach, Direct Lateral Approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Direct anterior approach
Arm Type
Active Comparator
Arm Description
Primary total hip arthroplasty using a direct anterior approach
Arm Title
Direct lateral approach
Arm Type
Active Comparator
Arm Description
Primary total hip arthroplasty using a direct lateral approach
Intervention Type
Procedure
Intervention Name(s)
direct anterior approach
Other Intervention Name(s)
modified Smith-Peterson approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
direct lateral approach
Other Intervention Name(s)
Hardinge approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle damage assay using Myoglobin biomarker
Description
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.
Time Frame
Day of surgery
Title
Muscle damage assay using Troponin T biomarker
Description
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.
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Functional outcome using Harris Hip Score
Description
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.
Time Frame
preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Functional outcome using the Oxford Hip Score Survey
Description
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.
Time Frame
preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Functional outcome using the 36-Item Short Form Health Survey (SF-36)
Description
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.
Time Frame
preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Functional outcome using the 20-meters-timed-walk(66 feet) test
Description
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).
Time Frame
at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Functional outcome using the Stair Climbing Test (SCT)
Description
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.
Time Frame
at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Post Operative Pain Medication Usage
Description
Postoperative, the amount of analgetics used by each patient is quantified (converted to opioid equivalent doses)
Time Frame
first 7 postoperative days - on a daily basis and then weekly for a 3 months period
Title
Pain assessment using the Visual Numeric Scale
Description
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).
Time Frame
first 7 postoperative days - on a daily basis and then weekly for a 3 months period
Title
Muscle damage - Creatine kinase (CK)
Description
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.
Time Frame
Day of operation and next 7 consecutive days
Title
Muscle damage - Lactate dehydrogenase (LDH or LD)
Description
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.
Time Frame
Day of operation and next 7 consecutive days
Title
Muscle damage assay using Aspartate aminotransferase (AST)
Description
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.
Time Frame
Day of operation and next 7 consecutive days
Title
radiological assessment of cup positioning in the replaced hip
Description
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.
Time Frame
first day postoperative
Title
radiological assessment of stem positioning in the replaced hip
Description
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.
Time Frame
first day postoperative
Title
radiological assessment of cup and stem osteointegration in the replaced hip
Description
The outcome measured is correct component osteointegration of the acetabular component and femoral stem using standard X-ray of the replaced hip.
Time Frame
12 months postoperative
Title
Length of Hospital Stay
Description
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.
Time Frame
10 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan V Nistor, MD
Organizational Affiliation
Iuliu Hatieganu University of Medicine and Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian Todor, MD, PhD
Organizational Affiliation
Iuliu Hatieganu University of Medicine and Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
16330993
Citation
Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.
Results Reference
background
PubMed Identifier
25799249
Citation
Petis S, Howard JL, Lanting BL, Vasarhelyi EM. Surgical approach in primary total hip arthroplasty: anatomy, technique and clinical outcomes. Can J Surg. 2015 Apr;58(2):128-39. doi: 10.1503/cjs.007214.
Results Reference
background
PubMed Identifier
24416475
Citation
Ilchmann T, Gersbach S, Zwicky L, Clauss M. Standard Transgluteal versus Minimal Invasive Anterior Approach in hip Arthroplasty: A Prospective, Consecutive Cohort Study. Orthop Rev (Pavia). 2013 Nov 6;5(4):e31. doi: 10.4081/or.2013.e31. eCollection 2013.
Results Reference
background
PubMed Identifier
23912418
Citation
Chechik O, Khashan M, Lador R, Salai M, Amar E. Surgical approach and prosthesis fixation in hip arthroplasty world wide. Arch Orthop Trauma Surg. 2013 Nov;133(11):1595-600. doi: 10.1007/s00402-013-1828-0. Epub 2013 Aug 4.
Results Reference
background
PubMed Identifier
26807354
Citation
Connolly KP, Kamath AF. Direct anterior total hip arthroplasty: Literature review of variations in surgical technique. World J Orthop. 2016 Jan 18;7(1):38-43. doi: 10.5312/wjo.v7.i1.38. eCollection 2016 Jan 18.
Results Reference
background
PubMed Identifier
26753844
Citation
De Anta-Diaz B, Serralta-Gomis J, Lizaur-Utrilla A, Benavidez E, Lopez-Prats FA. No differences between direct anterior and lateral approach for primary total hip arthroplasty related to muscle damage or functional outcome. Int Orthop. 2016 Oct;40(10):2025-2030. doi: 10.1007/s00264-015-3108-9. Epub 2016 Jan 12.
Results Reference
background
PubMed Identifier
26259051
Citation
Dayton MR, Judd DL, Hogan CA, Stevens-Lapsley JE. Performance-Based Versus Self-Reported Outcomes Using the Hip Disability and Osteoarthritis Outcome Score After Total Hip Arthroplasty. Am J Phys Med Rehabil. 2016 Feb;95(2):132-8. doi: 10.1097/PHM.0000000000000357.
Results Reference
background
Links:
URL
http://www.rne.ro/
Description
Romanian Arthroplasty Register
Learn more about this trial
Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty
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