Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty

NCT02719236 | Completed

• 1 other identifier: 517/2015
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis

Keywords

Coxarthrosis; Hip arthroplasty; Direct Anterior Approach; Direct Lateral Approach

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Functional outcome using Harris Hip Score

  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

  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)

  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

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

• Functional outcome using the Stair Climbing Test (SCT)

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

Study Arms (2)

Direct anterior approach

ACTIVE COMPARATOR

Primary total hip arthroplasty using a direct anterior approach

Procedure: direct anterior approach

Direct lateral approach

ACTIVE COMPARATOR

Primary total hip arthroplasty using a direct lateral approach

Procedure: direct lateral approach

Interventions

direct anterior approach PROCEDURE

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.

Also known as: modified Smith-Peterson approach

Direct anterior approach

direct lateral approach PROCEDURE

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.

Also known as: Hardinge approach

Direct lateral approach

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead
• Emergency County Hospital Cluj-Napoca: collaborator

Study Sites (1)

Emergency County Hospital Cluj-Napoca, Orthopedics and Trauma Clinic

Cluj-Napoca, Cluj, 400006, Romania

Location

Related Publications (7)

• 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.

  PMID: 16330993 BACKGROUND

• 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.

  PMID: 25799249 BACKGROUND

• 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.

  PMID: 24416475 BACKGROUND

• 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.

  PMID: 23912418 BACKGROUND

• 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.

  PMID: 26807354 BACKGROUND

• 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.

  PMID: 26753844 BACKGROUND

• 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.

  PMID: 26259051 BACKGROUND

Related Links

• Romanian Arthroplasty Register

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dan V Nistor, MD

  Iuliu Hatieganu University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

• Adrian Todor, MD, PhD

  Iuliu Hatieganu University of Medicine and Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan-Viorel Nistor MD

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 25, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RO (1)