Coxarthrosis Clinical Trial
— DAAvsDLAOfficial title:
Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty
NCT number | NCT02719236 |
Other study ID # | 517/2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | February 2020 |
Verified date | February 2021 |
Source | Iuliu Hatieganu University of Medicine and Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | February 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Romania | Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic | Cluj-Napoca | Cluj |
Lead Sponsor | Collaborator |
---|---|
Iuliu Hatieganu University of Medicine and Pharmacy | Emergency County Hospital Cluj-Napoca |
Romania,
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. — View 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. Review. — View 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. — View Citation
De Anta-Díaz B, Serralta-Gomis J, Lizaur-Utrilla A, Benavidez E, López-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. Epub 2016 Jan 12. — View 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. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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