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CoxarthrosisDAAvsDLANCT02719236

Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty

A study testing direct anterior approach and direct lateral approach in people with Coxarthrosis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Coxarthrosis
What is being tested?
direct anterior approach and direct lateral approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteRomania
Study dates
Mar 2015to Feb 2020
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 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Romania1 site
  • Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

About this study

Official title: Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty

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.

Read the 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.

Conditions
Coxarthrosis
Being tested
direct anterior approach, direct lateral approach
Keywords
Coxarthrosis, Hip arthroplasty, Direct Anterior Approach, Direct Lateral Approach
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • direct anterior approachProcedure or surgery

    Also called modified Smith-Peterson approach

    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.

  • direct lateral approachProcedure or surgery

    Also called Hardinge approach

    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.

Study groups in NCT02719236
Study groupRoleWhat they receive
Direct anterior approachActive comparatorPrimary total hip arthroplasty using a direct anterior approach
Receives: Procedure: direct anterior approach
Direct lateral approachActive comparatorPrimary total hip arthroplasty using a direct lateral approach
Receives: Procedure: direct lateral approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day of surgery

  2. 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.

    Measured: Day of surgery

Secondary outcomes (14)
  1. 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.

    Measured: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months

  2. 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.

    Measured: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months

  3. 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.

    Measured: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months

  4. 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).

    Measured: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months

  5. 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.

    Measured: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months

  6. Post Operative Pain Medication Usage

    Postoperative, the amount of analgetics used by each patient is quantified (converted to opioid equivalent doses)

    Measured: first 7 postoperative days - on a daily basis and then weekly for a 3 months period

  7. 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).

    Measured: first 7 postoperative days - on a daily basis and then weekly for a 3 months period

  8. 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.

    Measured: Day of operation and next 7 consecutive days

  9. 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.

    Measured: Day of operation and next 7 consecutive days

  10. 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.

    Measured: Day of operation and next 7 consecutive days

  11. 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.

    Measured: first day postoperative

  12. 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.

    Measured: first day postoperative

  13. 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.

    Measured: 12 months postoperative

  14. 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.

    Measured: 10 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719236
Sponsor's protocol ID
517/2015
Acronym
DAAvsDLA
Status last verified
Feb 2021
First submitted
12 Feb 2016
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 16330993
  • 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.

    PubMed 25799249
  • 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.

    PubMed 24416475
  • 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.

    PubMed 23912418
  • 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.

    PubMed 26807354
  • 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.

    PubMed 26753844
  • 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.

    PubMed 26259051

Questions about this trial

What is this clinical trial studying?

A study testing direct anterior approach and direct lateral approach in people with Coxarthrosis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

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 11 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 10 Feb 2021. 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 Romania. 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?

Muscle damage assay using Myoglobin biomarker (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02719236, which also lists 7 linked publications.

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 10 Feb 2021.

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