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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
Show all 11Show fewer
- 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
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 group | Role | What they receive |
|---|---|---|
| Direct anterior approach | Active comparator | Primary total hip arthroplasty using a direct anterior approach Receives: Procedure: direct anterior approach |
| Direct lateral approach | Active comparator | Primary 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted25 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency County Hospital Cluj-Napoca
- Responsible party
- Principal investigator, Dan Viorel Nistor, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Dan V Nistor, MD, Principal investigator, Iuliu Hatieganu University of Medicine and PharmacyAdrian Todor, MD, PhD, Study director, Iuliu Hatieganu University of Medicine and Pharmacy
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 16330993Petis 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 25799249Ilchmann 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 24416475Chechik 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 23912418Connolly 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 26807354De 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 26753844Dayton 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02719236
- Acronym / sponsor ID
- DAAvsDLA / 517/2015
- Conditions
- Coxarthrosis
- Keywords
- Coxarthrosis, Hip arthroplasty, Direct Anterior Approach, Direct Lateral Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Emergency County Hospital Cluj-Napoca
- Study start
- Mar 2015
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct anterior approach | Active comparator | Procedure: direct anterior approachPrimary total hip arthroplasty using a direct anterior approach |
| Direct lateral approach | Active comparator | Procedure: direct lateral approachPrimary total hip arthroplasty using a direct lateral approach |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| direct anterior approachAlso: modified Smith-Peterson approachThe 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. | Procedure or surgery | Direct anterior approach |
| direct lateral approachAlso: Hardinge approachThe 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. | Procedure or surgery | Direct lateral approach |
Primary outcome
Muscle damage assay using Myoglobin biomarker
Time frame: Day of surgery
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
Time frame: Day of surgery
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.
14 secondary outcomes
Functional outcome using Harris Hip Score
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Functional outcome using the Stair Climbing Test (SCT)
Time frame: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
Post Operative Pain Medication Usage
Time frame: first 7 postoperative days - on a daily basis and then weekly for a 3 months period
Pain assessment using the Visual Numeric Scale
Time frame: first 7 postoperative days - on a daily basis and then weekly for a 3 months period
Muscle damage - Creatine kinase (CK)
Time frame: Day of operation and next 7 consecutive days
Muscle damage - Lactate dehydrogenase (LDH or LD)
Time frame: Day of operation and next 7 consecutive days
Muscle damage assay using Aspartate aminotransferase (AST)
Time frame: Day of operation and next 7 consecutive days
radiological assessment of cup positioning in the replaced hip
Time frame: first day postoperative
radiological assessment of stem positioning in the replaced hip
Time frame: first day postoperative
radiological assessment of cup and stem osteointegration in the replaced hip
Time frame: 12 months postoperative
Length of Hospital Stay
Time frame: 10 days postoperative
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 10 Feb 2021.
- Background: PubMed 16330993Matta 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.
- Background: PubMed 25799249Petis 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.
- Background: PubMed 24416475Ilchmann 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.
- Background: PubMed 23912418Chechik 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.
- Background: PubMed 26807354Connolly 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.
- Background: PubMed 26753844De 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.
- Background: PubMed 26259051Dayton 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.
- Romanian Arthroplasty RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Dan V Nistor, MD principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy
Adrian Todor, MD, PhD study director
Iuliu Hatieganu University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
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.