Clinical trial NCT02719236: Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty
Official title: Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coxarthrosis
Keywords: Coxarthrosis
Hip arthroplasty
Direct Anterior Approach
Direct Lateral Approach
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Emergency County Hospital Cluj-Napoca
First posted: 2016-03-25
Enrollment: 112
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Muscle damage assay using Myoglobin biomarker
timeFrame: Day of surgery
measure: Muscle damage assay using Troponin T biomarker
timeFrame: Day of surgery
Secondary outcomes:
measure: Functional outcome using Harris Hip Score
timeFrame: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Functional outcome using the Oxford Hip Score Survey
timeFrame: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Functional outcome using the 36-Item Short Form Health Survey (SF-36)
timeFrame: preoperative,and at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Functional outcome using the 20-meters-timed-walk(66 feet) test
timeFrame: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Functional outcome using the Stair Climbing Test (SCT)
timeFrame: at follow-up visits at 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Post Operative Pain Medication Usage
timeFrame: first 7 postoperative days - on a daily basis and then weekly for a 3 months period
measure: Pain assessment using the Visual Numeric Scale
timeFrame: first 7 postoperative days - on a daily basis and then weekly for a 3 months period
measure: Muscle damage - Creatine kinase (CK)
timeFrame: Day of operation and next 7 consecutive days
measure: Muscle damage - Lactate dehydrogenase (LDH or LD)
timeFrame: Day of operation and next 7 consecutive days
measure: Muscle damage assay using Aspartate aminotransferase (AST)
timeFrame: Day of operation and next 7 consecutive days
measure: radiological assessment of cup positioning in the replaced hip
timeFrame: first day postoperative
measure: radiological assessment of stem positioning in the replaced hip
timeFrame: first day postoperative
measure: radiological assessment of cup and stem osteointegration in the replaced hip
timeFrame: 12 months postoperative
measure: Length of Hospital Stay
timeFrame: 10 days postoperative
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Dan V Nistor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Adrian Todor, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.